BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS TELEMETRY RECEIVER MODULE

    MDR report key: 4976720 · Received August 6, 2015

    Report

    Report Number
    3010157426-2015-00154
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 9, 2015
    Report Date
    August 6, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ONSITE TESTING OF THE INVOLVED DEVICES PERFORMED BY A SPACELABS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE EQUIPMENT PERFORMED TO SPECIFICATIONS. THE TESTING WAS WITNESSED BY A FACILITY STAFF MEMBER. REVIEW OF THE CUSTOMER PROVIDED PATIENT RETROSPECTIVE DATABASE WAS CONDUCTED BY A SPACELABS LEAD SOFTWARE ENGINEER. THE EVENT TIME WAS LOCATED IN THE DATABASE. TWO ECG LEADS WERE RECORDED FOR THIS EVENT. ALL NINE BEATS OF THE EVENT WERE DETECTED; HOWEVER, NOT ALL BEATS WERE CLASSIFIED AS VENTRICULAR. FOUR BEATS IN THE SERIES FROM ONE LEAD WERE CLASSIFIED AS NORMAL SINCE THEIR SHAPE AND AMPLITUDE MATCHED THE NORMAL BEATS FOR THIS LEAD. THERE WAS NO ALARM FOR THIS EVENT SINCE ALARM CRITERIA WAS NOT MET. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY RECEIVER MODULE MODEL 90478 WITH ARIATELE TRANSMITTER MODEL 96281 AND CENTRAL MONITOR MODEL 91387-38 FAILED TO GENERATE AN ALARM FOR NINE BEATS OF VENTRICULAR TACHYCARDIA (VTACH) ON (B)(6) 2015 AT 3:22 A.M. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520248 SPACELABS TELEMETRY RECEIVER MODULE TELEMETRY RECEIVER MODULE DSI SPACELABS HEALTHCARE INC. 90478

    Patients

    Seq Age Sex Outcome Treatment
    1