BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES FOR SPACE PUMPS

    MDR report key: 6052388 · Received October 24, 2016

    Report

    Report Number
    9610825-2016-00677
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Report Date
    September 29, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MRZ
    PMA / PMN Number
    K083689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE PROVIDED PICTURES WERE EXAMINED. ACCORDING TO THE PICTURES THE POWER SUPPLY SEEMED TO BE IN A BAD CONDITION AND SHOWED HEAVY MARKS OF USE. THE MALE CONNECTOR OF THE EXTENSION CABLE WAS MELTED DOWN. ASSUMEDLY AN HIGH AMOUNT OF FLUID CAUSED THIS THERMAL DAMAGE. FLUID HAS TO BE INGRESSED BETWEEN THE MALE CONNECTOR OF THE EXTENSION CABLE AND THE FEMALE CONNECTOR OF THE POWER SUPPLY UNIT. BASED ON FORMER TESTS, THIS ERROR PATTERN IS A RESULT OF USAGE OUT OF THE POWER SUPPLIES SPECIFICATION. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT 3: THE CUSTOMER IS REPORTING THERMAL DAMAGE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701970 ACCESSORIES FOR SPACE PUMPS US POWER CORD INCL. EXTENSION MRZ B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1