BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M

    MDR report key: 6135899 · Received November 30, 2016

    Report

    Report Number
    9610816-2016-00308
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    November 9, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSA
    PMA / PMN Number
    K020531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HEALTHY WOMAN WAS BEING MONITORED WHILE UNDER ANESTHESIA AND THE DEVICE REPORTED AN ASYSTOLE ALARM. CPR WAS STARTED BEFORE AN ASSESSMENT OF THE PATIENT'S VITAL SIGNS WERE MADE. IT WAS REPORTED THAT BLOOD PRESSURE AND RESPIRATIONS WERE BEING MONITORED AT THE SAME TIME. UNNECESSARY EMERGENT CARE WAS PROVIDED, THAT COULD HAVE CAUSED AN INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A HEALTHY WOMAN WAS BEING MONITORED WHILE UNDER ANESTHESIA AND THE DEVICE REPORTED AN ASYSTOLE ALARM. CPR WAS STARTED BEFORE AN ASSESSMENT OF THE PATIENT'S VITAL SIGNS WAS MADE. IT WAS REPORTED THAT BLOOD PRESSURE AND RESPIRATION WERE BEING MONITORED AT THE SAME TIME AS RCG. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY AS A RESULT OF THE TREATMENT THAT WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787454 5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M ECG TRUNK CABLE DSA PHILIPS MEDICAL SYSTEMS M1668A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR