BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F090705-1 GB DETACHABLE POWER CORD X1

    MDR report key: 11090898 · Received December 29, 2020

    Report

    Report Number
    1282497-2020-09816
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    November 29, 2020
    Report Date
    July 9, 2021
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING SITE, THE POWER CORD WAS DAMAGED, AND HAD A CUT AT THE FEMALE CONNECTOR END. THE ROOT CAUSE OF THE CUT MARK WAS RELATED TO USER MISUSE.

    Additional Manufacturer Narrative · 0

    ALL DEVICE HISTORY RECORDS ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR SHIPMENT. THE SERVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THIS IS THE FIRST TIME THAT THIS UNIT HAS BEEN RETURNED FOR SERVICE. THE RETURNED CABLE WAS INSPECTED, AND THE REPORTED ISSUE WAS CONFIRMED. UPON VISUAL EVALUATION, BURN MARKS CAN BE SEEN ON THE CABLE. THE ROOT CAUSE OF THE BURN MARKS CANNOT BE IDENTIFIED. DUE TO THE CONDITION OF THE CABLE, FUNCTIONAL TESTING COULD NOT BE CONDUCTED. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME AS THE ROOT CAUSE COULD NOT BE IDENTIFIED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    SECTION D4 HAS BEEN UPDATED TO INCLUDE THE UDI NUMBER OF (B)(4).

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION.  IF THE DEVICE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.  AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER CORD BURNED WITHOUT ANY WEAR AND TEAR OR KINKING. ADDITIONAL INFORMATION PROVIDED STATED THAT SPARKING AND ELECTRICAL ARCING HAD BEEN OBSERVED. THERE WAS NO INJURY OR HARM RELATED TO THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554214 F090705-1 GB DETACHABLE POWER CORD X1 SLEEVE, LIMB, COMPRESSIBLE JOW COVIDIEN 95251S

    Patients

    Seq Age Sex Outcome Treatment
    1