BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 6955343 · Received October 17, 2017

    Report

    Report Number
    3003477173-2017-00007
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 2, 2017
    Report Date
    October 17, 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. BRASS SHAVINGS WERE EVIDENT INSIDE THE CONNECTOR STEM AND ALONG THE M5 SCREW THREADS. THE CONNECTOR STEM HAD SOME SCRATCHES AT THE BOTTOM WHERE IT CONNECTS TO THE LOWER CLAMSHELL. THERE WAS ALSO SOME WEAR ON THE FACE OF THE ANCHOR LOWER NUT. THIS WEAR IS NOT NORMALLY OBSERVED IN USED DEVICES AND PRESUMABLY OCCURRED DURING SEPARATION. THE WASHER WAS BENT CONSIDERABLY BUT IT IS UNKNOWN WHEN THIS OCCURRED. WHEN THE STEM WAS REASSEMBLED WITH THE BENT WASHER THE STEM WASN'T ABLE TO BE FULLY SEATED. THIS RESULTED IN THAT ASSEMBLY BEING VERY LOOSE WHICH WOULD RESULTS IN A FAIR AMOUNT OF UNINTENDED MOVEMENT IN THE SYSTEM DURING USE. THERE WAS SOME WEAR AT THE END OF THE M5 SCREW INDICATING THAT, AT LEAST AT ONE TIME, THE SCREW WAS FULLY ENGAGED. INFORMATION ON CALIBRATION/MAINTENANCE EVENTS ON THIS DEVICE IS UNKNOWN THERE IS LITTLE EVIDENCE IF ANY OF CALIBRATION AS THE ADJUSTMENT SCREW IS IN GOOD CONDITION. IN SUMMARY, THE PROBLEM WITH THE DEVICE WAS THE UNINTENTIONAL SEPARATION OF THE STEM/SUCTION CUP ASSEMBLY FROM THE REST OF THE DEVICE DUE TO A PROBLEM DURING OPERATIONAL PERFORMANCE. WITHOUT BEING ABLE TO RE-CREATE THE FAILURE AND/OR FURTHER INFORMATION WE ARE UNABLE TO CONFIRM THE COMPLAINT.

    Description of Event or Problem · 1

    DURING PATIENT USE ON (B)(6), THE PLUNGER SEPARATED FROM THE HANDLE. THE CUSTOMER REVERTED TO MANUAL CPR UNTIL A REPLACEMENT ARRIVED ON SCENE. PATIENT WAS A (B)(6) YEAR OLD FEMALE. NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735228 RESQPUMP RESQPUMP PIZ

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR