BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 7832871 · Received August 30, 2018

    Report

    Report Number
    3003477173-2018-00004
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    August 13, 2018
    Report Date
    August 29, 2018
    Manufacturer
    ADVANCED CIRCULATORY SYSTEMS
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP ARRIVED WITH EVIDENCE IT HAD BEEN OPENED. THE STRAP HAD BEEN REMOVED WHICH CANNOT OCCUR WITHOUT THE CLAMSHELL BEING SEPARATED. THE FORCE GAUGE POINTER WAS AT 30 KG HOWEVER WAS UPSIDE DOWN INDICATING IT WAS REASSEMBLED INCORRECTLY, HOWEVER THIS IS NOT POSSIBLE DUE TO THE CLAMSHELL'S DESIGN. UPON OPENING THE CLAMSHELL IT WAS CLEAR THAT THE POINTER WAS NOT UPSIDE DOWN BUT THE TOP CLAMSHELL HAD BEEN REASSEMBLED UPSIDE DOWN. THE GAUGE SEEMED TO BE WORKING PROPERLY BUT WITH THE CLAMSHELL BEING UPSIDE DOWN IT APPEARED TO BE READING BETWEEN 30 AND 40. THE WHITE CONNECTOR STEM NOT TIGHTLY SECURED TO THE CLAMSHELL HANDLE AS A RESULT OF THE M5 SCREW NOT FULLY ENGAGED. GIVEN THAT THE PUMP HAD CLEARLY BEEN TAMPERED WITH, WE ARE UNABLE TO CONFIRM WHETHER THE DEVICE TRULY HAD A STUCK FORCE GAUGE AS THE CUSTOMER DESCRIBED OR JUST APPEARED TO DUE TO THE INCORRECT REASSEMBLY.

    Description of Event or Problem · 1

    THE RED ARROW ON THE FORCE GAUGE IS STAYING BETWEEN THE 30KG AND 40KG RANGE AND NOT RETURNING BACK TO THE NEUTRAL POSITION. CAPTAIN SAUDER PLACED THE RESQPUMP ON THE TABLE AND PUMPED UP AND DOWN. THE RED ARROW DID RETURN TO THE NEUTRAL POSITION, BUT WITHIN A FEW SECONDS FELL BACK DOWN TO THE BETWEEN THE 30KG AND 40KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674792 RESQPUMP RESQPUMP PIZ ADVANCED CIRCULATORY SYSTEMS 12-0823-000 50908708

    Patients

    Seq Age Sex Outcome Treatment
    1