BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES FOR SPACE PUMPS

    MDR report key: 5065147 · Received September 9, 2015

    Report

    Report Number
    9610825-2015-00385
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MRZ
    PMA / PMN Number
    K083689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE INVOLVED HAS BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE WAS RECEIVED AND ALL AVAILABLE INFORMATION WAS FORWARDED TO THE MANUFACTURER B. BRAUN MELSUNGEN. THE OUTER LIVE PIN WAS BENT AND THERMAL DAMAGE WAS FOUND ON THE POWER CORD. THE PINS OF THE POWER CORD THAT WAS PLUGGED INTO THE WALL MAY HAVE BEEN IN CONTACT WITH A CONDUCTIVE FLUID; ALSO A MECHANICAL DAMAGE COULD NOT BE EXCLUDED. THE REASON FOR THE THERMAL DAMAGE WAS CAUSED BY AN ELECTROLYSIS UNLEASHED BY A FLUID INGRESS BETWEEN THE CONTACT OF THE WALL SOCKET AND THE EXPECTED WET CONDUCTIVE PINS. BECAUSE OF THE CAPILLARY EFFECT THE LIQUID HAS THE ABILITY TO GET TO THE CONDUCTIVE PARTS OF THE POWER SUPPLY. IT SHOULD BE NOTED THAT THE INSTRUCTION FOR USE (IFU) FOR THE SPACE PUMP STATE "PROTECT THE DEVICE AND THE POWER SUPPLY FROM MOISTURE" AND ISO SYMBOL TO PROTECT FROM MOISTURE IS DISPLAYED ON THE POWER SUPPLY.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: THE CUSTOMER REPORTED "BROKEN PRONGS ON CHARGER" HOWEVER UPON RECEIPT OF THE SAMPLES ONE OF THE SAMPLES EXHIBITED THERMAL DAMAGE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596998 ACCESSORIES FOR SPACE PUMPS US. POWER CORD INCL. EXTENSION MRZ B. BRAUN MELSUNGEN AG 8713112D

    Patients

    Seq Age Sex Outcome Treatment
    1