BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 7958524 · Received October 11, 2018

    Report

    Report Number
    3003477173-2018-00005
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 18, 2018
    Report Date
    October 11, 2018
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESQPUMP ARRIVED WITH THE SUCTION CUP/CONNECTER STEM ASSEMBLY SEPARATED FROM THE HANDLE/SPRING ASSEMBLY. THE M5 WASHER WAS NOT INCLUDED IN THE RETURN HOWEVER THERE IS EVIDENCE THAT THERE HAD BEEN A WASHER INSTALLED PREVIOUSLY. WHEN OR HOW THE WASHER WAS SEPARATED FROM THE SYSTEM IS UNKNOWN. THERE WAS A GOOD AMOUNT OF WHITE PLASTIC SHAVINGS ON THE LOWER SPRING NUT AND INSIDE THE SUCTION CUP'S CONNECTION STEM RECESS. THE CLAMSHELL/STEM KEY FEATURE, WHICH ALIGNS THE TWO, SHOWED SIGNS OF DAMAGE AT THE TOP. THE DAMAGE IS PRESUMABLY DUE TO FRICTION WHILE THE M5 SCREW WAS IN THE PROCESS OF BACKING OUT. IT IS EVIDENT THAT THE M5 SCREW WAS ENGAGED IN THE THREADS (FULLY SEATED OR NOT IS UNKNOWN) AND BACKED OUT DURING OPERATION. BRASS SHAVINGS WERE IN THE SCREW THREADS ALONG THE ENTIRE ENGAGEMENT DEPTH INDICATING THAT, AT LEAST AT ONE TIME, THE SCREW WAS FULLY ENGAGED.

    Description of Event or Problem · 1

    THE RESQPUMP CAME APART DURING A RESUSCITATION EFFORT. AS FAR AS THE IMPACT IS UNKNOWN, MANUAL COMPRESSIONS WERE STARTED AND CONTINUED FROM THAT POINT FORWARD. I WAS NOT ON SCENE BUT AS FAR AS I CAN TELL, THE PT WAS BEING MOVED DOWN A FLIGHT OF STAIRS AND CPR BEING PERFORMED DURING THIS PROCESS. ONCE AT BOTTOM OF STAIRS THE DEVICE CAME APART LEAVING HALF ON PT CHEST AND OTHER HALF IN EMT'S HAND. IT SEEMS THAT THE NUT THAT HOLDS THE TWO TOGETHER CAME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797804 RESQPUMP RESQPUMP PIZ

    Patients

    Seq Age Sex Outcome Treatment
    1