BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPOD

    MDR report key: 2276047 · Received September 29, 2011

    Report

    Report Number
    MW5022458
    Event Type
    Malfunction
    Date Received
    September 29, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 29, 2011
    Manufacturer
    ACSI ADVANCED CIRCULATORY SYSTEMS, INC
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THERE IS AN APPARENT PROBLEM WITH THE RESQPOD DEVICE THAT ALLOWS THE TIMING LIGHT TO FUNCTION PROPERLY. THIS TIMING LIGHT IS USED TO TIME EACH RESPIRATION GIVEN TO THE PT. ASSOCIATE USING DEVICE STATED "AFTER OPENING THE RESQPOD, THE LIGHT WOULD NOT COME ON, IT WAS CHANGED OUT AND ONE THAT WORKED WAS OBTAINED." THIS ISSUE WAS IDENTIFIED ON TWO SEPARATE DEVICES WITH THE SAME LOT NUMBER. THE DEVICES WERE REMOVED FROM SERVICE AND SEQUESTERED FOR PICK UP BY THE VENDOR. NEW SUPPLIES WERE ORDERED IN AND STOCKED IN PLACE OF THE DEFECTIVE DEVICES. NO INJURY OR HARM CAME TO THE PT BECAUSE OF THIS EVENT. DATES OF USE: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESQPOD RESQPOD BWF ACSI ADVANCED CIRCULATORY SYSTEMS, INC 5826881

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR