BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC

    MDR report key: 11689176 · Received April 19, 2021

    Report

    Report Number
    3012307300-2021-03280
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Report Date
    May 27, 2021
    Product Code
    BTL
    UDI-DI
    10610586045486
    PMA / PMN Number
    K020899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: RETURNED DEVICE WAS RECEIVED FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED. NO FAULT FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL VENTILATOR DID NOT "PEEP" WHEN DIALED IN. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583821 PNEUPAC VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL 120003 10610586045486

    Patients

    Seq Age Sex Outcome Treatment
    1