BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL SCD

    MDR report key: 7215009 · Received January 24, 2018

    Report

    Report Number
    3008361498-2018-00043
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Report Date
    February 15, 2018
    Manufacturer
    COVIDIEN MFG PLAINFIELD
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ONE KENDALL SCD EXPRESS SEQUENTIAL COMPRESSION SYSTEM WAS RECEIVED FOR FAILURE ANALYSIS WITH A COMPLAINT OF "BACK TO STOCK". THE REPORTED SYMPTOM WAS VERIFIED, AS DURING TRIAGE SERVICE FOUND THERE TO BE EXPOSED COPPER WIRE. UPON VISUAL INSPECTION OF THE UNIT, THE POWER CORD WAS OBSERVED TO BE DAMAGED WITH EXPOSED COPPER WIRE. THE ROOT CAUSE OF THE REPORTED SYMPTOM WAS MISUSE/HANDLING. ALL DEVICE HISTORY RECORDS ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR SHIPMENT. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE PUMP WAS SENT IN AS A BACK TO STOCK UNIT. UPON TRIAGE THE SERVICE TECH FOUND THE PUMP TO HAVE A DAMAGED POWER CORD WITH EXPOSED COPPER WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61122 KENDALL SCD SLEEVE, LIMB, COMPRESSIBLE JOW COVIDIEN MFG PLAINFIELD U9525E

    Patients

    Seq Age Sex Outcome Treatment
    1