BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC

    MDR report key: 11802925 · Received May 10, 2021

    Report

    Report Number
    3012307300-2021-04174
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Report Date
    June 2, 2021
    Product Code
    BTL
    UDI-DI
    10610586045486
    PMA / PMN Number
    K020899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL VENTILATORS/PNEUPAC VENTILATORS PARAPAC COMPLAINT OF LEFT SIDE KNOB MISSING, RELEASE ALARM PRESSURE NOT WORKING AND WHERE THE GAGE IS MOUNTED IT IS BENT. THE UNIT WAS REPORTED TO BE DROPPED. PHYSICAL CONDITION OF DEVICE REVEALED FRONT PANEL BENT. MANOMETER GAUGE IS MISALIGNED INSIDE ALARM BEZEL ON AND OFF AND RELIEF ALARM PRESSURE KNOBS ARE MISSING. GAS SUPPLY INDICATOR DOES NOT REGISTER AIR PRESSURE BUT INPUT PASSES THE LOCK-OFF LEAK TEST. COMPLAINT WAS CONFIRMED AND ACTION WAS TAKEN TO REPLACE FRONT PANEL. REPAIR SUMMARY : REPLACED DAMAGED FRONT PANEL AND GAS SUPPLY INDICATOR. REPLACED MISSING SMALL KNOBS. READJUSTED MANOMETER INSIDE ALARM BEZEL. INSTALLED SERVICE KIT AS A PM.

    Description of Event or Problem · 0

    DEVICE ANALYSIS COMPLETED AND SUMMARY IN H 10.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE PNEUPAC VENTILATOR WAS RETURNED FOR INVESTIGATION IN USED CONDITION. VISUAL INSPECTION REVEALED THE FOLLOWING: THE FRONT PANEL WAS BENT, THE MANOMETER GAUGE WAS MISALIGNED INSIDE THE ALARM BEZEL, THE ON/OFF, AND THE RELIEF ALARM PRESSURE KNOBS WERE BOTH MISSING. IN ADDITION, THE GAS SUPPLY INDICATOR DID NOT REGISTER THE AIR PRESSURE. THE INPUT PASSED THE LOCK-OFF LEAK TEST, HOWEVER. THE CUSTOMER REPORTED PRODUCT PROBLEM WAS THEREFORE CONFIRMED. THE REPORTED ISSUES OCCURRED BECAUSE THE DEVICE HAD BEEN DAMAGED FROM AN IMPACT TO THE FRONT PANEL. A USER INTERFACE ISSUE WAS THEREFORE ESTABLISHED AS THE ROOT CAUSE. THE DAMAGED FRONT PANEL AND GAS SUPPLY INDICATOR, ALONG WITH THE OTHER DAMAGED/WORN COMPONENTS WERE REPLACED. THE DEVICE SUBSEQUENTLY PASSED ALL THE FUNCTIONAL TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RELEASE/ALARM PRESSURE ON THE PNEUPAC VENTILATOR WAS NOT WORKING. THE SECTION WHERE THE GAGE WAS MOUNTED WAS BENT. THE LEFT SIDE KNOB WAS ALSO MISSING. THE REPORTER ALSO INDICATED THAT THE DEVICE HAD BEEN DROPPED. THE AFOREMENTIONED PRODUCT ISSUES WERE OBSERVED DURING FUNCTIONAL TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696237 PNEUPAC VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL 120003 10610586045486

    Patients

    Seq Age Sex Outcome Treatment
    1