BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 7069048 · Received November 29, 2017

    Report

    Report Number
    3003477173-2017-00009
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 29, 2017
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS DAMAGE TO THE KEY IN THE LOWER CLAMSHELL THAT PREVENTS THE STEM FROM TURNING, THAT COULD HAVE OCCURRED WHEN THE STEM CAME OFF AND ANOTHER COMPRESSION CAME DOWN, BINDING UP THE GUIDE. THERE IS NOT SIMILAR DAMAGE ON THE MATING NOTCH IN THE STEM. THERE IS WHITE PLASTIC SHAVINGS INSIDE THE SOCKET ON THE SUCTION CUP THAT THE STEM INSERTS INTO. THERE IS ALSO SOME OF THE SAME INSIDE THE STEM, LIKELY FROM RUBBING ON THE SPRING. THE ORIGINAL PINK LOCTITE IS VISIBLE AT THE BASE OF THE BEVEL ON THE SCREW HEAD. THERE IS ALSO GREEN THREAD LOCKER ON ABOUT THE LAST 3/8" OF THREADS. THAT'S NOT FACTORY ISSUE, SO APPLIED AFTERWARDS. THE THREADS AREN'T STRIPPED OUT, AND THERE'S NOT MUCH EVIDENCE OF WEAR,,, BRASS SHAVINGS OR CORROSION. THE SCREW THREADS INTO THE BRASS SPRING END EASILY, THERE IS SOME PLAY, NOT EXCESSIVE. NO EVIDENCE OF TAMPERING OR DAMAGE WAS PRESENT ON THE INSIDE OF THE CLAMSHELL.

    Description of Event or Problem · 1

    DURING A CARDIAC ARREST, YESTERDAY, (B)(6) 2017 WE UTILIZED THE RESQPUMP ON A FEMALE PATIENT. DURING USE (A 20+ MINUTE ON SCENE EVOLUTION) THE PHILLIPS HEAD SCREW THAT IS VERTICALLY INSTALLED IN THE WHITE PLUNGER SECTION BACKED OUT AND CAUSED THE PUMP TO COME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847591 RESQPUMP RESQPUMP PIZ

    Patients

    Seq Age Sex Outcome Treatment
    1