BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 8384430 · Received March 2, 2019

    Report

    Report Number
    3003477173-2019-00005
    Event Type
    Malfunction
    Date Received
    March 2, 2019
    Date of Event
    February 5, 2019
    Report Date
    March 1, 2019
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FORCE GAUGE WAS ZEROED WHEN FIRST REMOVED FROM THE BOX. WHEN THE PUMP WAS COMPRESSED FOR THE FIRST TIME, IT GOT STUCK AT (B)(6). AFTER TAKING THE CLAMSHELL APART, THE SPRING AND GAUGE WERE IN THE CORRECT ORIENTATION. THE PUSHROD COULD BE PULLED OUT BUT IT WAS TOUGH TO DO SO. PART OF THE PUSHROD STEM WAS COVERED WITH LOCTITE. WHEN THE PUMP WAS REASSEMBLED, THE GAUGE WORKED NORMALLY. THE INVESTIGATION INDICATES THAT AN EXCESSIVE AMOUNT OF LOCTITE WAS PUT ON THE PUSHROD STEM WHICH CAUSED IT TO GET STUCK TEMPORARILY DURING COMPRESSION.

    Description of Event or Problem · 1

    THIS RESQPUMP WAS IDENTIFIED DURING THE DAILY CHECK OF THE DEVICE AND NOT DURING PATIENT CARE. THE RESQPUMP'S RED ARROW ON THE FORCE GAUGE STICKS AND DOES NOT ALWAYS RETURN TO THE "ZERO" POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177933 RESQPUMP PIZ

    Patients

    Seq Age Sex Outcome Treatment
    1