Panda iRes WarmerRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00840682103893), received between Apr 10, 2019 and Sep 28, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (13 reports).

17 other recalls cover devices cleared under the same FDA submission (K101804, K123309, K201628); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  It was reported that the side panel was broken. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914350 ↗
• MalfunctionSep 21, 2026Break

  It was reported that there was a side panel was broken. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838640 ↗
• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691926 ↗
• MalfunctionSep 1, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543055 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN SIDE PANEL LATCH WAS DAMAGED / BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134826 ↗
• MalfunctionApr 7, 2026No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808805 ↗
• MalfunctionMar 25, 2026No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687682 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SIDE RAIL DETACHED FROM THE BED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661626 ↗
• MalfunctionMar 20, 2026Crack

  IT WAS REPORTED THAT THE WEST PANEL WAS BROKEN IN HALF. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649452 ↗
• MalfunctionJan 9, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN UNAVAILABLE OXYGEN THERAPY DURING A CASE. THE PATIENT WAS TRANSFERRED TO A MAC VENTILATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022351 ↗
• MalfunctionNov 3, 2025Fire; Fire

  IT WAS REPORTED THAT SPARKS AND A FLAME OCCURRED AT THE ON/OFF SWITCH OF THE UNIT DURING A CASE. THE FLAME WAS EXTINGUISHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452008 ↗
• MalfunctionAug 25, 2025No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883418 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838910 ↗
• MalfunctionAug 6, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734383 ↗
• MalfunctionJul 14, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE FRONT PANEL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494464 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411914 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A BROKEN SIDE PANEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026626 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT THE SOUTH WALL PANEL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026104 ↗
• MalfunctionApr 22, 2025No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884451 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT THE FRONT PANEL LATCH WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860842 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A BROKEN FRONT WALL LATCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478002 ↗
• MalfunctionSep 23, 2019Material Integrity Problem; Material Integrity Problem

  THE HOSPITAL REPORTED A DAMAGED SIDE PANEL WHICH COULD CAUSE A PATIENT FALL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9103707 ↗
• MalfunctionSep 16, 2019Material Integrity Problem; Material Integrity Problem

  THE HOSPITAL REPORTED A BROKEN SIDE PANEL WHICH COULD CAUSE A PATIENT FALL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9070168 ↗
• MalfunctionSep 3, 2019Material Integrity Problem; Material Integrity Problem

  THE HOSPITAL REPORTED A BROKEN SIDE RAIL AND BASE WHICH COULD CAUSE A PATIENT FALL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8955808 ↗
• MalfunctionAug 26, 2019Material Integrity Problem; Material Integrity Problem

  THE HOSPITAL REPORTED THAT LATCHES ON THE FRONT PANEL ARE BROKEN WHICH COULD CAUSE A PATIENT FALL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8930768 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101804, K123309, K201628. One submission often covers many models, so check the product and lot details in each record.

• Z-2359-2026 · May 8, 2026 · Open, Classified
  Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenanc
• Z-2358-2026 · May 8, 2026 · Open, Classified
  Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if servi
• Z-3080-2024 · Aug 9, 2024 · Open, Classified
  GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based o
• Z-3081-2024 · Aug 9, 2024 · Open, Classified
  GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-010487
• Z-1847-2019 · Mar 15, 2019 · Terminated
  Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant
• Z-1846-2019 · Mar 15, 2019 · Terminated
  Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infa
• Z-0483-2019 · Sep 25, 2018 · Terminated
  Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
• Z-0482-2019 · Sep 25, 2018 · Terminated
  Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
• Z-0481-2019 · Sep 25, 2018 · Terminated
  Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
• Z-0484-2019 · Sep 25, 2018 · Terminated
  Panda Wall Mount warmer. Infant radiant warmer
• Z-1547-2014 · Apr 2, 2014 · Terminated
  Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitorin
• Z-1549-2014 · Apr 2, 2014 · Terminated
  Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrat
• Z-1550-2014 · Apr 2, 2014 · Terminated
  Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated
• Z-1548-2014 · Apr 2, 2014 · Terminated
  Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monito
• Z-0912-2014 · Dec 12, 2013 · Terminated
  Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe Infant Warmers provide infrared h

…and 2 more.