BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 7524200 · Received May 17, 2018

    Report

    Report Number
    3003477173-2018-00001
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    April 19, 2018
    Report Date
    May 17, 2018
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FIRST INSPECTION, THE D-RING (B)(4) WAS DISCONNECTED FROM THE UPPER CLAMSHELL WHICH COULD HAVE HAPPENED WHEN THE CUSTOMER OPENED THE CLAMSHELL. THE FORCE GAUGE WAS NON-FUNCTIONAL AS REPORTED AND WOULD INSTEAD MOVE WHEN THE PUMP WAS ROTATED FROM SIDE TO SIDE. THE SPRING (CURVE CYLINDER SPRING: (B)(4) WAS BACKWARDS WHICH IS WHAT CAUSED THE FORCE GAUGE NOT TO WORK. WHEN THE SPRING WAS PUT IN PROPERLY, THE FORCE GAUGE WORKED CORRECTLY. BECAUSE OF THESE THREE ISSUES (D-RING, SPRING, AND PCB OUT OF PLACE), IT IS LIKELY THAT THE CUSTOMER OPENED UP THE CLAMSHELL AND REASSEMBLED THE COMPONENTS INCORRECTLY. THE INCORRECTLY INSERTED SPRING CAUSED THE ISSUE WITH THE WITH THE FORCE GAUGE NOT WORKING. THIS PROBLEM BECAUSE WAS DUE TO THE CUSTOMER REASSEMBLING THE CLAMSHELL COMPONENTS INCORRECTLY, NOT A PROBLEM WITH THE DESIGN OR MANUFACTURING.

    Description of Event or Problem · 1

    RESQPUMP FOUND ON SHIFT CHECK DEAD BATTERY AND FORCE GAUGE STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364702 RESQPUMP PIZ 12-0823-000

    Patients

    Seq Age Sex Outcome Treatment
    1