Resuscitaire Radiant Warmer (RW82, RW82 VHA) MU20503Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04049098000215), received between Aug 24, 2022 and Aug 13, 2026 — classified as 3 deaths, 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 16, 2023Class IIOpen, Classified

   The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

   Z-1992-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236241 ↗
• InjuryJul 2, 2025Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE POSITIVE END-EXPIRATORY PRESSURE (PEEP) WAS TOO LOW WHEN THE MASK WAS FIRST PLACED ON THE PATIENT'S NOSE AND MOUTH. IT WAS NOTED THAT WHEN THE TUBE WAS PLUGGED IN AND VENTILATION WAS TURNED ON, THE PEEP VALUES WOULD FLUCTUATE DEPENDING ON IF THE TUBE WAS ATTACHED OR DETACHED, ESPECIALLY WHEN THE HOLE FROM ABOVE WAS CLOSED. THE BASE RATE OF THE FLOW WOULD CHANGE. THE PATIENT WAS A PREMATURE BABY WITH PNEUMOTHORAX AND A CHEST TUBE WAS INSERTED AS A MEASURE. THE DEVICE WAS TESTED ON (B)(6) 2025 AND WAS FOUND TO OPERATE ACCORDING TO MANUFACTURER'S SPECIFICATION.

  Patient problems: Pneumothorax

  MAUDE report 22386938 ↗
• DeathOct 2, 2024Gas Output Problem; Infusion or Flow Problem; Gas Output Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT A PREMATURE INFANT REQUIRED IMMEDIATE MEDICAL INTERVENTION USING A RESUSCITAIRE. REPORTEDLY, BOTH THE MATERNITY AND NEONATAL TEAMS HAD CHECKED THE EQUIPMENT BEFORE USE, CONFIRMING THAT IT WAS FUNCTIONING PROPERLY. DURING THE PROCESS OF GIVING BREATHS AND SUCTION TO THE NEWBORN, THE RESUSITAIRE SUDDENLY STOPPED WORKING. THE MATERNITY TEAM REPORTED THAT EITHER THE OXYGEN OR AIR CYLINDER HAD NOT BEEN TURNED ON. MEANWHILE, AND THE NEONATAL TEAM REPORTED THAT ONE OF THE CYLINDERS WAS EMPTY. THE INFANT WAS STABILIZED AND BROUGHT TO THE NEONATAL INTENSIVE CARE UNIT. THE PATIENT'S CONDITION DETERIORATED OVERNIGHT, AND THE PATIENT PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 20351272 ↗
• MalfunctionSep 11, 2024Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT THE RESUSCITAIRE HAD A POWER FAILURE WHILE THE PATIENT WAS BEING BORN. THE USER REPORTED THAT HEAT, OXYGEN, AIR, AND SUCTION WERE UNABLE TO BE USED, AND THAT THE USER COULD NOT TIME FOR A DELAYED CORD CLAMPING. THE PATIENT WAS OBSERVED AND WAS CONFIRMED TO BE HEALTHY. THERE WAS NO REPORT THAT THE PATIENT REQUIRED RESUSCITATION OR THAT THE MALFUNCTION PREVENTED ANY NECESSARY TREATMENT BEING POSTPONED, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189631 ↗
• MalfunctionMay 6, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED BY THE CUSTOMER THAT A DRAEGER RESUSCITAIRE HAD AN ERROR 5. THERE WERE PHOTOGRAPHS PROVIDED SHOWING THAT THE WARMER HOOD OF THE DEVICE WAS MELTED. IT WAS NOTED THAT THERE WAS A PATIENT INVOLVED, HOWEVER; THE CUSTOMER STATED THAT THERE WAS NO ADVERSE EVENT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249073 ↗
• DeathFeb 27, 2024Device Handling Problem; Suction Failure; Device Handling Problem; Suction Failure

  IT WAS REPORTED THAT A BABY WAS PLACED INTO A RESUSCITATOR AND PASSED AWAY DUE TO THE OXYGEN NOT BEING TURNED ON BY THE USERS.

  Patient problems: Insufficient Information; Low Oxygen Saturation; Respiratory Insufficiency

  MAUDE report 18787798 ↗
• InjuryNov 17, 2023No Pressure; No Pressure

  IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO BUILD-UP A SUFFICIENT AIRWAY PRESSURE, THE INTENDED PEEP COULD NOT BE KEPT AS WELL. FURTHER DETAILS ARE NOT KNOWN BY NOW AND THUS, THIS REPORT IS FILED IN ABUNDANCE OF CAUTION.

  Patient problems: Insufficient Information

  MAUDE report 18157906 ↗
• MalfunctionNov 9, 2023Fracture; Device Tipped Over; Fracture; Device Tipped Over

  IT WAS REPORTED THAT A CASTER OF THE DEVICE BROKE OFF CAUSING THE UNIT TO TOPPLE OVER. THERE WAS NO PATIENT INVOLVED BUT A NURSE WAS REPORTEDLY HIT BY THE DEVICE. THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT A SERIOUS INJURY HAD OCCURRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18099787 ↗
• MalfunctionOct 24, 2023Sparking; Sparking

  IT WAS REPORTED THAT THE USERS OBSERVED ELECTRICAL SPARKING INSIDE THE DEVICE. IT WAS CONFIRMED THAT THIS DID NOT LEAD TO AN INJURY FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993536 ↗
• MalfunctionOct 11, 2023Excessive Heating; Excessive Heating

  AS THE CUSTOMER REPORTED THE INFANT¿S SKIN TEMPERATURE WAS READING HIGHER THAN WHAT WAS SET ON THE RESUSCITAIRE. REPORTING BASED ON EVALUATION OF RECURRENCE POTENTIAL FOR HARM. NO ADVERSE IMPACT REPORTED.

  Patient problems: Hypothermia

  MAUDE report 17911695 ↗
• MalfunctionSep 28, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE TURNED-OFF BY ITSELF. INITIALLY, THE REPORT DID NOT CONTAIN ANY INFORMATION THAT THIS MAY HAVE OCCURRED DURING PATIENT USE. UPON REQUEST FOR FURTHER INFORMATION, DRÄGER WAS MADE AWARE THAT A PATIENT WAS INVOLVED AND THAT THE EVENT LED TO A DELAY IN PATIENT TREATMENT REQUIRING RESUSCITATION. NO HEALTH CONSEQUENCES FOR PATIENT HAVE FINALLY OCCURRED.

  Patient problems: Bradycardia

  MAUDE report 17832073 ↗
• MalfunctionSep 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DRAEGER RESUSCITAIRE MAY NOT HAVE BEEN DELIVERING ADEQUATE OXYGEN. THERE WAS A TEMPORARY DESATURATION REPORTED BUT NO FURTHER SYMPTOMS OR CONSEQUENCES.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17742987 ↗
• MalfunctionSep 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN INACCURACY OF THE WEIGHING RESULTS WAS OBSERVED WITH THE DEVICE'S SCALE. AS PER REPORT, THIS DID NOT LEAD TO DIRECT OR INDIRECT CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17668656 ↗
• DeathSep 7, 2022Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT AN EVENT OCCURRED WHERE THE INVOLVED PATIENT DIED. THE USERS NOTED THE WARMER [RESUSCITAIRE] WAS MALFUNCTIONING AND HAD PROVIDED A CHECK TEMP ALARM.

  Patient problems: Insufficient Information

  MAUDE report 15374678 ↗
• InjuryAug 24, 2022Gas Output Problem; Protective Measures Problem; Gas Output Problem; Protective Measures Problem

  ON (B)(6) 2022 IT WAS REPORTED THAT WHILE THE CUSTOMER WAS SPOT TESTING THE PEAK INSPIRATORY PRESSURE OF THE RESUSCITATION MODULE (MULTIPLE DEVICES, EXACT S/N NOT PROVIDED) WITH AN ANALOG MANOMETER (CUSTOMER'S TESTING EQUIPMENT) THAT THEY HAVE OBSERVED A BRIEF SPIKE IN PRESSURE HOWEVER THE RESUSCITAIRE UNIT DOES NOT SHOW A SPIKE AND DOES NOT CLIMB PAST THE SET PRESSURE. NOTE THAT THE SPOT TESTING BEING PERFORMED IS NOT A DRAEGER TEST FOR THE DEVICE. THE CUSTOMER HAS RAISED CONCERNS THAT THE POTENTIAL SPIKE (THEY HAVE OBSERVED DURING THEIR OWN TESTING) IN PRESSURE COULD POTENTIALLY CAUSE A PNEUMOTHORAX IN A PATIENT. CURRENTLY THE CUSTOMER IS NOT USING THE RESUSCITATION MODULE OF THE DEVICE WHILE WAITING ON FEEDBACK FROM DRÄGER. ON 29APR2022 NEW INFORMATION WAS RECEIVED. THE SITE RESPIRATORY THERAPIST STATED ¿THAT THEY DO NOT GET PNEUMOS [PNEUMOTHORAX, A COLLAPSED LUNG] USING THE STANDALONE BLENDER¿. THOUGH NO SPECIFIC PATIENT DETAILS HAVE BEEN PROVIDED TO DATE, THIS INDICATES AN ALLEGATION THAT WHEN THE RESUSCITAIRE RESUSCITATION MODULE WAS USED ON PATIENTS, PNEOMOS OCCUR (PATIENT INJURY). ADDITIONAL INFORMATION WAS REQUESTED REGARDING ANY EVENTS WHERE A PATIENT EXPERIENCED A PNEUMO

  Patient problems: Insufficient Information

  MAUDE report 15288695 ↗