BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 7071239 · Received November 30, 2017

    Report

    Report Number
    3003477173-2017-00008
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    October 31, 2017
    Report Date
    November 30, 2017
    Product Code
    PIZ
    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 WITH NO APPARENT EVIDENCE OF MODIFICATION OR MISUSE OF THE DEVICE. STEELE SHAVINGS WERE EVIDENT INSIDE THE CONNECTOR STEM AND UNDER THE M5 SCREW HEAD. THERE IS DAMAGE TO THE KEY IN THE LOWER CLAMSHELL THAT PREVENTS THE STEM FROM TURNING. THIS PROBABLY OCCURRED WHEN THE STEM BECAME PARTIALLY DISENGAGED (ENDUSER STATED THE STEM SEEMED TO GET DISLODGED BEFORE FULL SEPARATION) AND ANOTHER COMPRESSION CAME DOWN. THERE IS NO DAMAGE ON THE MATING NOTCH IN THE STEM. INFORMATION ON CALIBRATION/MAINTENANCE EVENTS ON THIS DEVICE IS UNKNOWN. THERE IS EVIDENCE OF CALIBRATION AS THERE WAS LOCTITE AT THE BOTTOM OF THE SCREW WHICH IS NOT APPLIED THERE DURING MANUFACTURING.

    Description of Event or Problem · 1

    DURING COMPRESSION RESQPUMP SEPARATED INTO TWO PARTS: HANDLE, PUMP. MANUAL CPR CONTINUED AND A SECOND DEVICE WAS USED TO CONTINUE ITD THERAPY. NO EFFECT ON OUTCOME OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849204 RESQPUMP PIZ

    Patients

    Seq Age Sex Outcome Treatment
    1