Bio-Med Devices, Inc. 2003GERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00813841020010), received between May 18, 2023 and Apr 20, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 reports).

3 FDA recall records name this device's identifier, 3 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 8, 2026Class IOpen, Classified

   Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

   Z-2358-2026 · Root cause: Process control · Recall details · FDA record ↗

2. May 8, 2026Class IOpen, Classified

   Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

   Z-2357-2026 · Root cause: Process control · Recall details · FDA record ↗

3. May 8, 2026Class IOpen, Classified

   Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

   Z-2359-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Gas Output Problem

  AIR/OXYGEN BLENDER IN RESUSC MODULE HAD LOOSE CONTROL SHAFT EXTENDER, AFFECTING BLENDER OUTPUT. THERE WAS A TEMPORARY PATIENT DESATURATION (DELAY IN TREATMENT). NO INJURY TO PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24925065 ↗
• MalfunctionJan 27, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY DURING PRE-USE SET-UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240830 ↗
• MalfunctionDec 13, 2024Insufficient 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 20926558 ↗
• MalfunctionJun 12, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AN OXYGEN LEAK DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518676 ↗
• MalfunctionJun 4, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457375 ↗
• MalfunctionMay 17, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339857 ↗
• MalfunctionMar 20, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AN OXYGEN LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939366 ↗
• MalfunctionMar 7, 2024Mechanical Problem; Mechanical Problem

  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 18861559 ↗
• InjuryDec 28, 2023Decrease in Pressure; Decrease in Pressure

  THE HOSPITAL REPORTED THAT UPON DELIVERY, A FETUS IN A GIRAFFE IRS WARMER HAD AN INITIAL HEART RATE OF LESS THAN 60 AND THEY INITIATED USE OF THE INTEGRATED RESUSCITATION DEVICE. THE FACILITY ATTEMPTED TO USE A T-PIECE, BUT THERE WAS NO CHEST RISE. IT APPEARED THAT THERE WAS A SUDDEN LOSS OF PRESSURE FROM THE DEVICE AND THAT THE PEAK INSPIRATORY PRESSURE (PIP) WAS NOT ADEQUATE EVEN THOUGH THERE WAS A GOOD SEAL ON THE FACE MASK. A LARYGEAL (I-GEL) WAS PLACED IN CONJUNCTION WITH THE T-PIECE PROVIDING CHEST RISE. HOWEVER, THE HEART RATE REMAINED LESS THAN 60. THE INFANT WAS THEN INTUBATED AND TRANSFERRED TO THE NICU. INFANT BLOOD GAS UPON ARRIVAL IN NICU, REVEALED SEVERE ACIDOSIS AND MODERATE TO SEVERE HIE (HYPOXIC-ISCHEMIC ENCEPHALOPATHY). GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Low Cardiac Output; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408699 ↗
• MalfunctionMay 18, 2023Gas Output Problem; Gas Output Problem

  THE USER COULD NOT ADJUST THE OXYGEN % WITH CONTROL KNOB AS DESIRED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953190 ↗