BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD 700 COMPRESSION SYSTEM-US

    MDR report key: 4121464 · Received September 26, 2014

    Report

    Report Number
    3006451981-2014-00721
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    ONE SCD 700 WAS RETURNED FOR INVESTIGATION FOR THE REPORTED CONDITION OF; POWER CORD WAS BURNT. INITIAL INSPECTION OF THE POWER CORD SHOWED IT FAILED TO MEET OPERATIONAL SPECIFICATIONS BECAUSE CORD WAS FOUND BURNT THROUGH OUTER INSULATION, CONFIRMING THE REPORTED CONDITION. AN ANALYSIS OF SIMILAR COMPLAINTS HAS FOUND THE ROOT CAUSE TO BE TWO TYPICAL FAILURE MODES FOR A BURNED POWER CORD ON AN SCD EXPRESS: THERE IS AN ELECTRICAL SHORT IN THE WALL OUTLET AND THE AC INPUT PINS ARE BURNED. THE CORD IS WRAPPED TOO TIGHTLY AROUND THE BED HOOK OR THE UNIT IS SUPPORTED BY THE CORD, WHICH PUTS STRESS ON THE CORD WHERE IT MEETS THE STRAIN RELIEF. OVER TIME, THE INTERNAL WIRES BREAK AND EVENTUALLY SHORT TOGETHER, SHOWING AN EXTERNAL BURN MARK WHERE THE SOOT FROM THE INTERNAL WIRES SHORTING EXITS THE OUTER SHEATH. POWER CORDS PERIODICALLY REQUIRE REPLACEMENT DUE TO AGE, USAGE AND USER DAMAGE. THE POWER CORD WAS REPLACED TO CORRECT THE PROBLEM. A PRESSURE TRANSDUCER WAS REPLACED FOR PREVENTATIVE MAINTENANCE. THE UNIT WAS FULLY TESTED AND PASSED ALL OPERATIONAL SPECIFICATIONS. PRODUCT SCD 700 WAS MANUFACTURED IN 2013. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THIS DEVICE WAS RELEASED MEETING ALL MANUFACTURING SPECIFICATIONS. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH THE SCD POWER CORD. THE CUSTOMER STATES THAT THE POWER CORD IS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601990 SCD 700 COMPRESSION SYSTEM-US SCD POWER CORD JOW COVIDIEN 29525 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1