BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARA PAC

    MDR report key: 12081456 · Received June 28, 2021

    Report

    Report Number
    3012307300-2021-06611
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 29, 2021
    Report Date
    June 28, 2021
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL VENTILATORS/PNEUPAC VENTILATORS PARAPAC DEVICE FAILED WHILE TRANSPORTING PATIENT. INTERMITTENTLY GIVING BREATH, DEVICE STOPPED CYCLING ALL TOGETHER AND THEN IT PRECEDED TO CYCLE INTERMITTENTLY. THE LAST TIME IT WAS SERVICED WAS MAY 14 2021 BY SMITHS MEDICAL. NO INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977785 PARA PAC VENTILATOR BTL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR