BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS COMPRESSION SYSTEM

    MDR report key: 4759977 · Received May 8, 2015

    Report

    Report Number
    3008361498-2015-00005
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 5, 2015
    Manufacturer
    PLAINFIELD
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE REPORTED CONDITION WAS PERFORMED ON (B)(6) 2015 BY (B)(6). ONE SCD EXPRESS COMPRESSION SYSTEM WAS RETURNED FOR INVESTIGATION FOR THE REPORTED CONDITION OF; THE CUSTOMER STATED ON (B)(6) 2015 THAT THE (ELW IS NOT CHARGED AND THE) UNIT HAS A DEAD BATTERY. UPON TRIAGE ON (B)(4) 2015 THE SERVICE TECH FOUND EXPOSED COPPER FROM A CUT OFF CORD. THE BED HOOK WAS REPLACED TO CORRECT THE PROBLEM. INITIAL INSPECTION OF THE POWER CORD FOUND IT WAS CUT WHICH EXPOSED THE INTERNAL WIRES. BOTH THE AC HIGH AND GROUND WIRES WERE SEVERED AT THE SAME POINT, CONFIRMING THE REPORTED CONDITION. THE EXPOSED WIRES CREATE A HIGH RISK OF A HAZARDOUS CONDITION TO EITHER THE PATIENT OR THE CLINICAL STAFF. POWER CORDS PERIODICALLY REQUIRE REPLACEMENT DUE TO AGE, USAGE AND USER DAMAGE. THE SERVICE MANUAL INSTRUCTS THE USER TO PERIODICALLY INSPECT THE POWER CORDS RESISTANCE TO ENSURE ITS ELECTRICAL SAFETY. THE POWER CORD WAS REPLACED TO CORRECT THE PROBLEM. PRODUCT SCD EXPRESS WAS MANUFACTURED IN 2007. 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.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, AN UPDATED INVESTIGATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED ON (B)(6) 2015 THAT THE (ELW IS NOT CHARGED AND THE) UNIT HAS A DEAD BATTERY. UPON TRIAGE ON (B)(6) 2015 THE SERVICE TECH FOUND EXPOSED COPPER FROM A CUT OFF CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304622 SCD EXPRESS COMPRESSION SYSTEM SCD CONTROLLER JOW PLAINFIELD 9525 V0750360

    Patients

    Seq Age Sex Outcome Treatment
    1