BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 LEAD ECG TRUNK AAMI/IEC 2M

    MDR report key: 2771401 · Received September 27, 2012

    Report

    Report Number
    9610816-2012-00428
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Report Date
    July 13, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K020531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT NO SIGNAL WAS CAPTURED FOR THE V4 LEAD VIA THE M1663A ECG TRUNK CABLE DURING PT. IT WAS CONFIRMED THAT THERE WAS NO PT INCIDENT/INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10 LEAD ECG TRUNK AAMI/IEC 2M MHX PHILIPS MEDICAL SYSTEMS M1663A 1B

    Patients

    Seq Age Sex Outcome Treatment
    1