MEDLINE CPRM4426FPWMRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10197344100484), received between Mar 12, 2026 and May 15, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Disconnection

  IT WAS REORTED THAT MD AND RN WERE MANUALLY VENTILATING THE PATIENT WITH AMBU BAG BUT THE O2 TUBING AND RESERVOIR TO THE AMBU BAG WAS DISCONNECTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25193093 ↗
• MalfunctionApr 29, 2026Imprecise or Erratic Results

  IT WAS REPORTED THAT A NEONATAL PATIENT IN THE ICU EXPERIENCED A DETERIORATION IN VITAL SIGNS, PROMPTING THE CARE TEAM TO INITIATE MANUAL VENTILATION. WHEN THE MANUAL RESUSCITATION BAG WAS SQUEEZED, THE PRESSURE MANOMETER DID NOT MOVE, AND THE CARE TEAM WAS UNSURE WHETHER EFFECTIVE BREATHS WERE BEING DELIVERED, AS CHEST RISE WAS DIFFICULT TO ASSESS. IT WAS LATER DETERMINED THAT THE ENDOTRACHEAL TUBE HAD BECOME DISPLACED PRIOR TO MANUAL VENTILATION. A NEW MANUAL RESUSCITATION BAG WAS OBTAINED AND PLACED INTO USE, AND THE PATIENT'S ENDOTRACHEAL TUBE WAS REMOVED AND REPLACED. FOLLOWING THESE INTERVENTIONS, THE PATIENT'S VITAL SIGNS NORMALIZED AND THE PATIENT'S CONDITION IMPROVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029099 ↗
• MalfunctionMar 20, 2026Crack; Material Integrity Problem

  IT WAS REORTED THAT CONNECTION POINT CRACKED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24655924 ↗
• MalfunctionMar 19, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE RESUSCITATION BAG WAS LEAKING AIR AT THE CONNECTION POINT. THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646311 ↗
• MalfunctionMar 12, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE RESUSCITATION BAG WAS LEAKING AIR, WITH THE OXYGEN AREA INTERMITTENTLY POPPING OFF THE BACK, RESULTING IN INADEQUATE OXYGEN DELIVERY DURING RESUSCITATION. THE CUSTOMER ALSO REPORTED THAT AN UNSPECIFIED INJURY OCCURRED DURING THE EVENT; HOWEVER, NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580889 ↗