FMT

Death

4

Malfunction

3,074

Total

3,078

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K243606 — Babyroo TN300 Draeger Medical Systems, Inc. · 2025-01-17
• K230278 — Babyroo TN300 Draeger Medical Systems, Inc. · 2023-05-30
• K213551 — Giraffe Omnibed Carestation CS1 Datex Ohmeda, Inc. · 2022-03-02
• K201628 — Panda iRes Warmer, Giraffe Warmer GE Healthcare · 2021-02-12
• K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable Deroyal Industries, Inc. · 2020-04-02
• K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover Deroyal Industries, Inc. · 2020-01-21
• K173516 — NuBorne Infant Warmer International Biomedical · 2018-08-17
• K123309 — GIRAFFE AND PANDA WARMERS Ohmeda Medical · 2013-02-05
• K120642 — RESUSCITAIRE WITH AUTOBREATH Draeger Medical Systems, Inc. · 2012-11-02
• K122267 — GIRAFFE AND PANDA WARMERS Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 2012-10-02
• K121625 — LULLABY TM WARMER Wipro GE Healthcare Private, Ltd. · 2012-09-14
• K120937 — SUNFLOWER WARNER Atom Medical Corporation · 2012-07-06
• K102227 — INFA WARMER I Atom Medical Corporation · 2011-01-21
• K101804 — GIRAFFE AND PANDA WARMERS Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 2010-07-21
• K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER Ohmeda Medical · 2009-04-16
• K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) Ohmeda Medical · 2007-08-27
• K070377 — GIRAFFE AND PANDA WARMER Ohmeda Medical · 2007-07-11
• K060461 — V-505 INFA WARMER Atom Medical, Inc. · 2006-04-28
• K033040 — PHOENIX INFANT RADIANT WARMER, MODEL 100NWS International Hospital Supply Co. · 2003-12-17
• K020966 — RPI REPLACEMENT HEATING ELEMENTS Replacement Parts Industries, Inc. · 2002-06-13
• K020219 — RPI SKIN OR AIR TEMPERATURE PROBE Replacement Parts Industries, Inc. · 2002-04-12
• K012229 — SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC National Custom Ent., Inc. · 2001-09-10
• K003335 — RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER Hill-Rom Air-Shields · 2000-11-17
• K002355 — ATOM INFA WARMER V-505 Atom Medical Corp · 2000-10-10
• K971366 — INCUWARMER Hill-Rom, Inc. · 1998-01-05
• K972885 — SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 Fisher & Paykel Electronics , Ltd. · 1997-10-30
• K971198 — BABYTHERM 8004 BABYTHERM 8010 Drager, Inc. · 1997-10-03
• K970686 — ACCUTEMP-PROBE Kentec Medical, Inc. · 1997-08-25
• K971695 — SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER Fisher & Paykel Electronics , Ltd. · 1997-07-28
• K971461 — SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) Fisher & Paykel Electronics , Ltd. · 1997-07-16
• K970432 — INFANT RADIANT WARMER - MODELS IW910 AND IW920 Fisher & Paykel Electronics , Ltd. · 1997-05-07
• K970074 — STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) Hill-Rom, Inc. · 1997-04-03
• K964401 — KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) Ludlow Technical Products · 1997-02-06
• K950422 — FIRST TOUCH DISPOSABLES TEMPERATURE PROBES First Touch Disposables, Inc. · 1997-01-23
• K963058 — INFANT WARMER SYSTEM Ohmeda Medical · 1996-10-01
• K960080 — ACCUTEMP PROBE Kentec Medical, Inc. · 1996-05-01
• K952800 — TEMPERATURE PROBE-TP150 Contour Medical Technology, Inc. · 1996-04-04
• K952801 — TEMPERATURE PROBE-TP250 Contour Medical Technology, Inc. · 1996-04-04
• K952803 — TEMPERATURE PROBE-TP350 Contour Medical Technology, Inc. · 1996-04-04
• K952804 — TEMPERATURE PROBE-TP450 Contour Medical Technology, Inc. · 1996-04-04
• K952805 — TEMPERATURE PROBE-TP550 Contour Medical Technology, Inc. · 1996-04-04
• K952807 — TEMPERATURE PROBE-TP650 Contour Medical Technology, Inc. · 1996-04-04
• K953489 — DRAGER INFANT RADIANT WARMERN RH600 Drager, Inc. · 1996-02-09
• K946005 — ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE Astral, Ltd. · 1995-09-25
• K950143 — ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE Astral, Ltd. · 1995-09-25
• K940951 — RW RESUCITAIRE INFANT RADIANT WARMER Air-Shields, Inc. · 1995-05-03
• K942905 — DISPOSABLE TEMPERATURE PROBE COVER Arbo Medical, Inc. · 1995-02-27
• K942904 — STABILET Hill-Rom, Inc. · 1994-09-16
• K934677 — U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE U.S. Medical Corp. · 1994-07-05
• K935609 — 4002 INFANT SCALE FOR INCUBATORS AND WARMERS Scale-Tronix, Inc. · 1994-07-01
• K931529 — INFANT WARMER Medix I.C.S.A. · 1994-03-11
• K926030 — KLEAR-TEMP Cas Medical Systems, Inc. · 1994-02-24
• K925006 — HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO Deroyal Industries, Inc. · 1994-01-31
• K921547 — ADVANTAGE Kci · 1993-07-23
• K921766 — OHIO INFANT WARMER SYSTEM Ohmeda Medical · 1993-04-23
• K912921 — VSI 1000 Vitaltrends Technology, Inc. · 1992-10-30
• K915831 — THERMAL PROBE COVER Vermont Medical, Inc. · 1992-06-08
• K913945 — STABILET INFANT RADIANT WARMER MODEL 2000C Hill-Rom, Inc. · 1992-02-12
• K910915 — PATIENT WARMER MODEL 100C Developmed Corp. · 1991-07-16
• K885350 — PREEMICARE SERIES 2000 INFANT WARMER Preemicare Corp. · 1989-08-07
• K884280 — MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET Gempco, Inc. · 1988-12-22
• K884283 — MODEL WC-107 MOBILE NEWBORN BED Gempco, Inc. · 1988-12-22
• K884285 — MODEL WC-115 MOBILE BASSINET Gempco, Inc. · 1988-12-22
• K881670 — ACCUTEMP PLUS Sentry Medical Products, Inc. · 1988-11-22
• K884160 — OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM Ohmeda Medical · 1988-11-21
• K881713 — SPECIAL PROCEDURES BASE UNIT MODEL 500 Gempco, Inc. · 1988-07-12
• K875270 — INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS Air-Shields, Inc. · 1988-01-19
• K872742 — WARM WEIGH MODELS I-20/W-30 INFANT SCALE Air-Shields, Inc. · 1987-10-20
• K871177 — NTH 101 UL Aragona Medical, Inc. · 1987-10-09
• K871178 — MTC XI UL Aragona Medical, Inc. · 1987-10-09
• K871594 — BIRTHING ROOM WARMER Air-Shields, Inc. · 1987-06-05
• K862921 — MODEL 10200 PREMATURE INFANT INCUBATOR Rotem Industries C/O Medsys, Inc. · 1987-04-01
• K865012 — YSI MODEL 801 Yellow Springs Instrument Co., Inc. · 1987-03-04
• K863208 — OHMEDA AUXILIARY POWER SYSTEM Ohmeda Medical · 1986-10-03
• K861781 — DELIVERY ROOM WARMER Air-Shields, Inc. · 1986-07-15
• K853926 — NEOCARE MODEL 800 INFANT RADIANT WARMER Draeger Medical, Inc. · 1986-02-26
• K852943 — NEO SHIELD Gaymar Industries, Inc. · 1985-11-08
• K853351 — OHMEDA HEAT REFLECTING PATCH Ohmeda Medical · 1985-10-17
• K853794 — NEOGUARD REFLECTOR Cas Medical Systems, Inc. · 1985-10-16
• K851449 — OHMEDA 5000 INFANT WARMER SYSTEM Ohmeda Medical · 1985-06-07
• K850069 — BORNING NEONATAL RESUSCITATOIN CENTER Borning Corp. · 1985-05-30
• K840792 — INFANT RADIANT WARMER Hatch Bio Medical · 1984-05-25
• K833802 — INFANT WARMER Kinetic Concepts, Inc. · 1984-04-05
• K840857 — OHIO 3000 INFANT WARMER SYSTEM Ohio Medical Products · 1984-03-23
• K840858 — OHIO 3300 INFANT WARMER SYSTEM Ohio Medical Products · 1984-03-23
• K832637 — AMEDA NEONATAL RESUSCITATION UNIT- Egnell, Inc. · 1983-12-22
• K830748 — RESUSCITAIRE Vickers America Medical Corp. · 1983-06-22
• K813408 — SAGE 2200 STERILE SPECIMEN CONTAINER Sage Products, Inc. · 1982-01-25
• K812745 — WARMING LISTHTS #96H & 96HT J. H. Emerson Co. · 1981-11-02
• K802365 — OHIO RADIANT WARMER Ohio Medical Products · 1980-10-23
• K790948 — TEMP-GUARD TM Gordon Consultants, Inc. · 1979-09-24
• K790137 — INFANT CARE SYSTEM Narco Air-Shields · 1979-03-06