BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECH ATTACH CABLE

    MDR report key: 3123868 · Received May 15, 2013

    Report

    Report Number
    2183456-2013-00003
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    March 7, 2013
    Report Date
    May 15, 2013
    Manufacturer
    AD TECH MEDICAL INSTRUMENT
    Product Code
    IKD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVED CATALOG NUMBER L-DCL-10DIN, A 10 CONTACT TECH ATTACH CABLE. ON (B)(6) 2013, PRIOR TO PT USE, THE BIOMED DEPT OF CLEVELAND CLINIC TESTED THE PRODUCT CONNECTORS USING A VOLT METER. WHEN CONNECTOR #9 WAS TESTED, THE VOLT METER MOVED WHEN HITTING #10 AND WHEN CONNECTOR #10 WAS TESTED THE VOLT METER MOVED WHEN HITTING #9. IT APPEARS CONNECTORS #9 AND #10 ARE REVERSED AND MISLABELED ON THE BLACK PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215020 TECH ATTACH CABLE CABLE IKD AD TECH MEDICAL INSTRUMENT 213270

    Patients

    Seq Age Sex Outcome Treatment
    1