BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 7144242 · Received December 22, 2017

    Report

    Report Number
    3003477173-2017-00010
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    October 30, 2017
    Report Date
    December 22, 2017
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE METRONOME BUTTON WAS PUSHED, NO SOUND WAS GENERATED. AFTER TAKING THE CLAMSHELL APART, THE PCB AND FLEX-CIRCUIT WERE INSPECTED FOR IRREGULARITIES. SOME CORROSION WAS IDENTIFIED ON THE FLEX-CIRCUIT ALONG WITH SOME PARTICULATE ON THE INSIDE OF THE CLAMSHELL. NO GROSS ERRORS WERE DETECTED ON THE PCB (MISSING COMPONENTS, BROKEN SOLDER JOINTS) BUT CORROSION WAS IDENTIFIED AT ONE OF THE BATTERY TERMINALS ALONG WITH POTENTIAL DAMAGE TO THE BATTERY ITSELF. WHEN A DIFFERENT PCB AND BATTERY WERE USED, THE METRONOME WORKED. RESQPUMPS GETTING STUCK IN THE COMPRESSED POSITION IS BEING INVESTIGATED UNDER CAPA (B)(4)-MAIN. BECAUSE THIS INVESTIGATION IS STILL ONGOING, FER (B)(4) WAS ALSO INSPECTED FOR THIS ISSUE. WHEN THE PUMP WAS COMPRESSED, THE FORCE GAUGE WAS STUCK AT 50 KG. WHEN THE CLAMSHELL WAS TAKEN APART, ALL COMPONENTS SEEMED TO BE IN THE CORRECT ORIENTATION. THE PUSHROD COULD BE REMOVED BUT IT WAS HARDER TO DO SO THAN AVERAGE. A SIGNIFICANT PORTION OF THE PUSHROD STEM WAS COVERED WITH AN EXCESSIVE AMOUNT OF LOCTITE. WHEN THE PUMP WAS REASSEMBLED, THE PUMP WOULD STILL STICK AT 50 KG AFTER THE FIRST COMPRESSION. THE INVESTIGATION INDICATES THAT MOISTURE WAS INTRODUCED TO THE INSIDE OF THE CLAMSHELL CAUSING CORROSION AND SUBSEQUENT BATTERY DEPLETION. IT ALSO INDICATES THAT AN EXCESSIVE AMOUNT OF LOCTITE WAS PUT ON THE PUSHROD STEM WHICH CAUSE IT TO GET STUCK AT THE POINT OF MAXIMUM COMPRESSION.

    Description of Event or Problem · 1

    ORIGINALLY REPORTED AS A METRONOME STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921464 RESQPUMP PIZ 12-0823-000

    Patients

    Seq Age Sex Outcome Treatment
    1