BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 6918766 · Received October 5, 2017

    Report

    Report Number
    3003477173-2017-00006
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 6, 2017
    Report Date
    September 5, 2017
    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

    THE TRESQPUMP APPEARED IN GOOD CONDITION WITH NO OBVIOUS SIGNS OF DAMAGE OR TAMPERING. THE FORCE GAUGE WAS ZEROED WHEN FIRST REMOVED FROM THE BOX. WHEN THE PUMP WAS COMPRESSED TO 50 KG, THE FORCE GAUGE WOULD SLOWLY RETURN TO ZERO AFTER THE FORCE WAS REMOVED. AFTER ADDITIONAL COMPRESSIONS, THIS ISSUE WOULD DECREASE IN FREQUENCY BUT NOT CEASE COMPLETELY. THE GAUGE ALSO WOULDN'T MOVE WHEN THE PUMP WAS PLACED UNDER A DECOMPRESSION FORCE OF -15 KG. AFTER TAKING THE CLAMSHELL APART, ALL COMPONENTS SEEMED TO BE IN THE CORRECT ORIENTATION. THE PUSHROD COULD BE REMOVED BUT WAS SLIGHTLY MORE DIFFICULT TO DO THAN AVERAGE. A SIGNIFICANT PORTION OF THE STEM WAS COVERED WITH AN EXCESSIVE AMOUNT OF LOCTITE. WHEN THE PUMP WAS REASSEMBLED, IT SEEMED TO BE WORKING CORRECTLY. THE DECOMPRESSION ISSUE ALSO SEEMED TO BE RESOLVED. THE ACCURACY OF THE FORCE GAUGE WAS VERIFIED ON A SCALE AND HAD THE FOLLOWING RESULTS WHICH ARE WITHIN SPECIFICATION: FORCE GAUGE = 50 KG: SCALE = 47 KG AND FORCE GAUGE = -15 KG: SCALE = -16 KG. THE INVESTIGATION SUGGESTS THAT AN EXCESSIVE AMOUNT OF LOCTITE WAS PUT ON THE PUSHROD STEM CAUSING THE FORCE GAUGE TO RETURN SLOWLY TO ZERO.

    Description of Event or Problem · 1

    MEDICS CALLED TO SCENE OF A FULL ARREST. GAUGE ON RESQPUMP WAS NOT WORKING, SEEMED STUCK. IT IS REPORTED THAT THE RESQPUMP WAS NOT USED ON THE PATIENT. NOTIFIED THE CUSTOMER OF A STUCK GAUGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696988 RESQPUMP RESQPUMP PIZ

    Patients

    Seq Age Sex Outcome Treatment
    1