BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS TELEMETRY RECEIVER MODULE

    MDR report key: 3944932 · Received July 18, 2014

    Report

    Report Number
    3010157426-2014-00053
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    September 13, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED THE RETROSPECTIVE PATIENT DATABASE, WHICH WAS REVIEWED BY A SPACELABS LEAD SOFTWARE ENGINEER. ECG WAVEFORMS WERE EXTRACTED FROM THE DATA AND RE-PLAYED THROUGH AN ANALOG SYSTEM FOR ANALYSIS TO CONFIRM INTERPRETATION FROM THE ECG ALGORITHM CONTAINED WITHIN THE TELEMETRY RECEIVER MODULE. THE ECG ALGORITHM AND ANALOG ANALYSIS DID NOT GENERATE AN ALARM AT THE EVENT TIME BECAUSE THE THRESHOLD CLASSIFICATION FOR RECOGNITION OF VFIB BY THE PRODUCT WAS NOT MET. THIS EVENT HAD LOW WAVEFORM AMPLITUDE AND ABERRANT MORPHOLOGY WITH SUBTLE DIFFERENCES IN TIMING, SLOPE AND BEAT INTERVALS FROM THE TWO ECG LEADS USED FOR ANALYSIS. LOW WAVEFORM AMPLITUDE AND OTHER ECG SIGNAL ISSUES ARE DISCUSSED IN THE SPACELABS CLINICAL PARAMETERS MANUALS PROVIDED TO THE CUSTOMER. IN CONCLUSION, THERE WAS NO EQUIPMENT MALFUNCTION. SPACELABS VFIB ALARM THRESHOLDS WERE NOT MET THEREFORE NO ALARM WAS GENERATED. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE INCIDENT DEVICE ONSITE. SPACELABS IS FOLLOWING UP WITH THE FSE TO GET MORE INFORMATION. FULL DISCLOSURE DATA WAS PROVIDED BY THE CUSTOMER. INVESTIGATION IS UNDERWAY. WE WILL FILE A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS CONCLUDED. PLACEHOLDER.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITORED WITH TELEMETRY TRANSMITTER MODEL 96281, RECEIVER MODULE MODEL 90478 AND CENTRAL MONITOR MODEL 91387-38 FAILED TO GENERATE AN ALARM FOR VENTRICULAR FIBRILLATION WITH TORSADE (VFIB) ON (B)(6) 2014 AT 11:55 P.M. THE PATIENT¿S INTERNAL CARDIAC DEFIBRILLATOR DETECTED AND TREATED THE VFIB RETURNING THE PATIENT TO A NORMAL CARDIAC RHYTHM. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY CENTRAL MONITOR FAILED TO ALARM ON VENTRICULAR FIBRILLATION (V-FIB). PATIENT WAS SHOCKED WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CONVERTED TO A PACED RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421626 SPACELABS TELEMETRY RECEIVER MODULE TELEMETRY RECEIVER MODULE DSI SPACELABS HEALTHCARE INC. 90478

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 91387-38,96281 ((B)(4))