BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES FOR SPACE PUMPS

    MDR report key: 2850298 · Received November 1, 2012

    Report

    Report Number
    9610825-2012-00225
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K083689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MANUFACTURER), AND (B)(4) (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT #(B)(4). VISUAL EXAMINATION REVEALED OBVIOUS TRACES OF AN ELECTRONIC FIRE THAT OCCURRED BETWEEN THE U.S. POWER CORD AND POWER SUPPLY. THERE WERE SOOT MARKS EVIDENT ACROSS THE ENTIRE CONNECTION OF THE PRIMARY ADAPTER (POWER CORD) AND THE POWER SUPPLY. THE P2 CONNECTOR LOCK WAS BROKEN OFF. BECAUSE OF THE DESTRUCTION, THE FUNCTION OF THE POWER SUPPLY COULD NOT BE CHECKED. THE SAMPLE AND ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THE MANUFACTURER'S INVESTIGATION INTO THIS EVENT IS ON-GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: (B)(4), SERIAL # UNKNOWN, 1 ITEM, REPORTED (B)(6) 2012, OCCURRED (B)(6) 2012. REPORTS NURSE HEARD A POPPING SOUND COMING FROM A PT'S ROOM. OBSERVED SMOKE EMITTING FROM THE ELECTRICAL CORD AT THE EXTENSION. NO PT INJURY, PT WAS REMOVED FROM THE ROOM DUE TO SMOKE. HOSPITAL ELECTRICIAN CHECKED THE ELECTRICAL OUTLETS AND COULD NOT FIND ANY INDICATION THE ISSUE WAS FROM THE OUTLETS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other