BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS DIGITAL TELEMETRY

    MDR report key: 2930305 · Received January 25, 2013

    Report

    Report Number
    3023361-2013-00012
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    November 12, 2012
    Report Date
    July 8, 2013
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ONE WAS INJURED AS A RESULT OF THIS REPORTED EVENT. SPACELABS IS EVALUATING THIS REPORT AND WILL FILE A FOLLOW UP REPORT WHEN OUR EVALUATION IS CONCLUDED.

    Additional Manufacturer Narrative · 1

    NO ONE WAS INJURED AS A RESULT OF THIS REPORTED EVENT. A SPACELABS FIELD SERVICE ENGINEER WAS SENT ONSITE TO EVALUATE THE DEVICE. THE TELEMETRY TRANSMITTER WAS TESTED AT THE CUSTOMER SITE ACCORDING TO CURRENT SPECIFICATIONS AND PASSED. SPACELABS HAS CONCLUDED THE TELEMETRY WAS FUNCTIONING ACCORDING TO SPECIFICATIONS. SPACELABS CONSIDERS THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    A CUSTOMER CLAIMED THAT A SPACELABS TELEMETRY RECEIVER MODULE, MODEL NUMBER 90478, DID NOT ALARM DURING A VENTRICULAR TACHYCARDIA EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CLAIMED THAT A SPACELABS TELEMETRY RECEIVER MODULE, MODEL NUMBER 90478, DID NOT ALARM DURING A VENTRICULAR TACHYCARDIA EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35772 SPACELABS DIGITAL TELEMETRY TELEMETRY DSI SPACELABS MEDICAL INC. 90478

    Patients

    Seq Age Sex Outcome Treatment
    1