BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS, INC.

    MDR report key: 746975 · Received November 1, 2005

    Report

    Report Number
    MW1037078
    Event Type
    Malfunction
    Date Received
    November 1, 2005
    Date of Event
    October 26, 2005
    Report Date
    November 1, 2005
    Manufacturer
    *
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ECC MODULE FAILED TO ALARM WHEN THE PATIENT WENT INTO V-FIB. THE UNIT DID NOT ALARM THROUGHOUT RESUSCITATION EFFORTS. PATIENT CARE WAS NOT DELAYED DUE TO THE ALARM FAILURE. THE PATIENT'S OUTCOME -DEATH- WAS NOT AFFECTED BY THE ALARM FAILURE. THE ALARMS WERE TURNED ON AND THEY WERE NOT SILENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS, INC. ECG/RESPIRATIONS MODULE MHX * 90470-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR