Pneupac 510A1960NONEURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019517181173), received between Oct 13, 2022 and Jul 23, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED, THAT THE AIR INDICATOR WAS FAULTY. THE EVENT OCCURRED, DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806054 ↗
• MalfunctionJul 2, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE DEVICE WAS SHOWING RESULTS OUR OF RANGE DURING TESTING. IT WAS ALSO STATED THAT THE DEVICE EXHIBITED CONTINUOUS FLOW AND DID NOT VENTILATE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660496 ↗
• MalfunctionOct 25, 2023Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THE DEVICE STOPPED CYCLING. CUSTOMER STATED THAT NO PATIENT HARM AND MEDICAL INTERVENTION WAS RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007612 ↗
• MalfunctionOct 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING THE TRANSFER OF A NEWBORNS. ADVERSE PATIENT EFFECTS ARE UNKNOWN AND THE OUTCOME OF THE EVENT WAS LISTED AS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 17857123 ↗
• MalfunctionOct 13, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT SEVERAL TIMES WHILE TESTING THE DEVICE ONE CONTINUOUS INSULATION BREATH WHEN TURNING THE KNOB. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600778 ↗
• MalfunctionOct 13, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE OSCILLATOR NEEDED TO BE REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600760 ↗