BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 7571479 · Received June 5, 2018

    Report

    Report Number
    3003477173-2018-00003
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    April 25, 2018
    Report Date
    June 5, 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 PUMP APPEARED TO BE IN GOOD CONDITION WITH NO OBVIOUS SIGNS OF TAMPERING OR DAMAGE. THE FORCE GAUGE COULD MOVE BUT WOULD SOMETIMES GET STUCK TEMPORARILY DURING COMPRESSION. ALL OF THE COMPONENTS INSIDE THE CLAMSHELL WERE IN THE RIGHT PLACE. THE PUSHROD COULD BE REMOVED BUT IT WAS HARDER TO DO THAN AVERAGE. A SIGNIFICANT PORTION OF THE STEM WAS COVERED WITH AN EXCESSIVE AMOUNT OF LOCTITE. WHEN THE PUMP WAS REASSEMBLED, THE PUMP WOULD STILL GET STUCK TEMPORARILY. THIS INDICATES THAT AN EXCESSIVE AMOUNT OF LOCTITE WAS USED ON THE PUSHROD STEM WHICH CAUSED IT TO GET STUCK TEMPORARILY DURING COMPRESSION.

    Description of Event or Problem · 1

    METRONOME STOPPED WORKING, FOUND ON SHIFT CHECK. FORCE GAUGE STICKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413339 RESQPUMP PIZ

    Patients

    Seq Age Sex Outcome Treatment
    1