BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC POWER PLUG

    MDR report key: 1628976 · Received December 9, 2009

    Report

    Report Number
    MW5015060
    Event Type
    Injury
    Date Received
    December 9, 2009
    Report Date
    December 9, 2009
    Manufacturer
    ELECTRI-CORD MFG. CO. MN. OFFICE
    Product Code
    LDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    (B) (4). FDA SAFETY INVESTIGATION OF CERTAIN MEDICAL DEVICE POWER CORDS MANUFACTURED BY ELECTRI-CORD. SO FAR THE FOLLOWING COMPANIES HAVE NOTIFIED USERS THAT THEY MAY HAVE THE RECALLED ELECTRI-CORD POWER CORD ON THEIR EQUIPMENT: (B) (4). I HAVE FOLLOWED THE ATTACHED FLOW CHART AND HAVE DETERMINED THAT THE POWER CORD/PLUG IS AFFECTED BY THE FDA RECALL AND IS EXHIBITING ONE OF THE CHARACTERISTICS AS FOLLOWS: IF THE PLUG HAS BENT OR CRACKED PRONGS, AN OUTER SHEATH THAT IS VISIBLY BURNT, A BLACK RESIDUE, SIGNS OF EXCESSIVE WEAR AND TEAR. I HAVE TAKEN THE FOLLOWING ACTIONS: CONTACT OF THE MEDICAL DEVICE MANUFACTURER OR SALES REPRESENTATIVE TO REPORT THE POWER CORD FAILURE AND TO REQUEST THE APPROPRIATE REPLACEMENT/REPAIR. I HAVE REMOVED THE POWER PLUG/CORD ASSEMBLY, REPLACED WITH A VERIFIED CORRECT COMPONENT, SAFETY TESTED, AND RETURNED EQUIPMENT BACK INTO SERVICE. THE (B) (4) SUPERVISOR HAS BEEN NOTIFIED OF THIS WORK ORDER FOR THE NEED TO REPORT TO THE FDA. (B) (4) DATES OF USE: 3 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER PLUG AC POWER PLUG LDQ ELECTRI-CORD MFG. CO. MN. OFFICE TALLER BRIDGE PLUG TALLER BRIDGE

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability