BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC VENTILATOR

    MDR report key: 9532680 · Received December 30, 2019

    Report

    Report Number
    3012307300-2019-07478
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Report Date
    April 8, 2020
    Product Code
    BTL
    UDI-DI
    10610586045486
    PMA / PMN Number
    K020899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: RETURNED DEVICE WAS RECEIVED WITH THE BATTERY HOLDER ASSEMBLY DAMAGED AND BATTERY IS MISSING. DURING THE EVALUATION OF THE DEVICE THE CUSTOMER REPORTED CONDITION WAS CONFIRMED, VISUAL INSPECTION OF DEVICE CONFIRMED THAT THE BATTERY HOLDER IS DAMAGED. ALSO NOTICED THE BATTERY IS MISSING. PROBLEM SOURCE WAS TRACED TI USER INTERFACE. THE PREVIOUS SERVICE HISTORY WAS REVIEWED, RO# 1012715 30-SEP-2019 CAME IN FOR "DAMAGED BATTERY HOLDER."

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC PARAPAC VENTILATOR HAD NO BATTERY POWER AND THAT THE BATTERY WAS DAMAGED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327553 PNEUPAC PARAPAC VENTILATOR VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL 120003 10610586045486

    Patients

    Seq Age Sex Outcome Treatment
    1