BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES FOR SPACE PUMPS

    MDR report key: 3770143 · Received April 4, 2014

    Report

    Report Number
    2523676-2014-00092
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    March 27, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: MATING CONNECTION BETWEEN THE PUMP AND POWER CORD HAS INCURRED A CATASTROPHIC FAILURE RESULTING IN THERMAL DAMAGE TO THE UNIT. INCIDENT DID NOT IMPACT PT OR CLINICIAN SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204837 ACCESSORIES FOR SPACE PUMPS US POWER CORD INCL. EXTENSION FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK