BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS TELEMETRY RECEIVER MODULE

    MDR report key: 4741367 · Received April 30, 2015

    Report

    Report Number
    3010157426-2015-00096
    Event Type
    Malfunction
    Date Received
    April 30, 2015
    Date of Event
    April 1, 2015
    Report Date
    June 16, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USING THE PATIENT RETROSPECTIVE DATABASE PROVIDED BY THE CUSTOMER AND REVIEWED BY A SPACELABS LEAD SOFTWARE ENGINEER, A 25 BEAT EPISODE OF VENTRICULAR TACHYCARDIA (VTACH) WAS LOCATED FOR THE REPORTED EVENT. THERE WAS AN ASSOCIATED ALARM FOR THIS EVENT. THERE WAS A 13 BEAT VTACH EPISODE FOLLOWING THE 25 BEAT EPISODE WITH A 5.5 SECOND SEPARATION OF NORMAL BEATS. WHEN THERE IS LESS THAN 10 SECONDS SEPARATING TWO EPISODES OF VTACH, THE DATABASE REPORTS IT AS ONE LONG EPISODE INSTEAD OF TWO. THIS IS BY DESIGN. THERE WAS NO MALFUNCTION. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    ONSITE TESTING BY A SPACELABS FIELD SERVICE ENGINEER (FSE) WAS DECLINED BY THE CUSTOMER SINCE THE EQUIPMENT WAS STILL IN USE. SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS ISSUE AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE. PLACEHOLDER.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2015 AT 3:17 A.M. A TELEMETRY PATIENT MONITORED WITH TRANSMITTER MODEL 90343-5, RECEIVER MODULE MODEL 90478 AND CENTRAL MONITOR MODEL 91387-38 EXPERIENCED VENTRICULAR TACHYCARDIA (VTACH). THERE WAS NO ALARM GENERATED AT THE CENTRAL MONITOR AND NO RECORDING IN THE ALARMS TAB FOR ICS-G2 FOR THIS EVENT. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284167 SPACELABS TELEMETRY RECEIVER MODULE TELEMETRY RECEIVER MODULE DSI SPACELABS HEALTHCARE INC. 90478

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)