BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 6510141 · Received April 20, 2017

    Report

    Report Number
    3003477173-2017-00001
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    February 24, 2017
    Report Date
    April 13, 2017
    Manufacturer
    ADVANCED CIRCULATORY
    Product Code
    PIZ
    UDI-DI
    M5921208230001
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP ARRIVED PARTIALLY ASSEMBLED. THE M5 WASHER WASN'T INCLUDED IN THE RETURN HOWEVER THERE IS EVIDENCE THAT THERE HAD BEEN A WASHER INSTALLED PREVIOUSLY. WHEN OR HOW THE WASHER WAS SEPARATED FROM THE SYSTEM IS UNKNOWN. THE ON -SCENE SUPERVISOR REPORTED THAT THE PUMP HAD BEEN IN USE FOR OVER 30 MINUTES BEFORE THE FAILURE OCCURRED. IT IS EVIDENT THAT THE M5 SCREW WAS ENGAGED IN THE THREADS (FULLY SEATED OR NOT IS UNKNOWN) AND BACKED OUT DURING OPERATION. BRASS SHAVINGS WERE IN THE SCREW THREADS ALONG THE ENTIRE ENGAGEMENT DEPTH INDICATING THAT, AT LEAST AT ONE TIME, THE SCREW WAS FULLY ENGAGED. THE THREADS WERE FAIRLY LOOSE BUT NOT COMPLETELY STRIPPED. THE CLAMSHELL/STEM KEY FEATURE, WHICH ALIGNS THE TWO, SHOWED SIGNS OF DAMAGE AT THE TOP. INFORMATION ON CALIBRATION/MAINTENANCE EVENTS ON THIS DEVICE HAS BEEN REQUESTED AS THE SCREW IN QUESTION IS REMOVED DURING CALIBRATION. THE IFU PROVIDES THE RE-CALIBRATION INSTRUCTIONS FOR THE USER TO RE-ZERO THE FORCE GAUGE. THIS INCLUDES REMOVING THE SUCTION CUP, LOOSENING THE SCREW AND REASSEMBLING THE DEVICE. THERE IS EVIDENCE OF CALIBRATION AS THE ADJUSTMENT SCREW HEAD IS PARTIALLY STRIPPED. THE USER HAS NOT CONFIRMED ANY MAINTENANCE PERFORMED. IN SUMMARY, THE PROBLEM WITH THE DEVICE WAS THE UNINTENTIONAL SEPARATION OF THE STEM/SUCTION CUP ASSEMBLY FROM THE REST OF THE DEVICE DUE TO A PROBLEM DURING OPERATIONAL PERFORMANCE. WITHOUT BEING ABLE TO RE-CREATE THE FAILURE AND/OR FURTHER INFORMATION WE ARE UNABLE TO CONFIRM THE COMPLAINT.

    Description of Event or Problem · 1

    WHILE USING THE RESQPUMP TO PERFORM CPR ON A PATIENT ON THE FLOOR OF A RESIDENCE, THE RESCUE PUMP MALFUNCTIONED AND SEPARATED INTO TWO PIECES. THE SOFT PLASTIC PLUNGER SEPARATED FROM THE HARD PLASTIC BASE DURING THE UPWARD PORTION OF THE NORMAL COMPRESSION CYCLE. THE PUMP WAS POSITIONED APPROPRIATELY ON THE CHEST AND SEEMED TO BE WORKING FINE THROUGH SEVERAL CYCLES OF USE AND THROUGH MULTIPLE USERS UNTIL IT STARTED TO GET LOOSE AND FINALLY SEPARATE. WE WERE ABLE TO CONTINUE CPR AND RETRIEVE ANOTHER DEVICE TO CONTINUE THE RESUSCITATION EFFORT. A QUICK EXAMINATION OF THE DEVICE ON SCENE SHOWED THAT A MAIN CENTER SCREW IN THE DEVICE HAD BACKED OUT TO THE POINT OF DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288345 RESQPUMP RESQPUMP PIZ ADVANCED CIRCULATORY 12-0823-000 50908708 M5921208230001

    Patients

    Seq Age Sex Outcome Treatment
    1