BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS TELEMETRY RECEIVER MODULE

    MDR report key: 6112918 · Received November 18, 2016

    Report

    Report Number
    3010157426-2016-00183
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 24, 2016
    Report Date
    January 10, 2017
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K983996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONSITE TESTING BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT THE INVOLVED DEVICES PERFORMED TO SPECIFICATIONS. THE TESTING WAS WITNESSED BY A HOSPITAL REPRESENTATIVE. THE PATIENT'S HISTORICAL WAVEFORMS AND TREND INFORMATION WAS COLLECTED BY THE FSE AND SENT TO SPACELABS FOR ANALYSIS. SPACELABS WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S HISTORICAL WAVEFORMS AND TREND INFORMATION WERE REVIEWED BY A SPACELABS SOFTWARE ENGINEER. FINDINGS SHOW THAT THE TELEMETRY RECEIVER MODULE DETECTED THE EPISODE AND GENERATED AN ASYSTOLE ALARM. THE DEVICE PERFORMED TO SPECIFICATIONS. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE IS CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2016 AT APPROXIMATELY 5:41 AM THE CENTRAL MONITOR DID NOT ALARM WHEN A TELEMETRY PATIENT EXPERIENCED AN EPISODE OF ASYSTOLE. THE PATIENT FELL AND HIT HER HEAD DURING THE EPISODE (CAT SCAN NEGATIVE) AND REMAINS HOSPITALIZED WITH NO FURTHER REPORTED CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765627 SPACELABS TELEMETRY RECEIVER MODULE TELEMETRY RECEIVER MODULE DSI SPACELABS HEALTHCARE INC. 90478

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other