BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS DIGITAL TELEMETRY TRANSMITTER

    MDR report key: 2512084 · Received April 2, 2012

    Report

    Report Number
    3023361-2012-00012
    Event Type
    Malfunction
    Date Received
    April 2, 2012
    Date of Event
    March 7, 2012
    Report Date
    April 1, 2012
    Manufacturer
    SPACELABS MEDICAL INC
    Product Code
    MHX
    PMA / PMN Number
    K983996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER (FSE) TESTED THE SUBJECT DEVICE IN THE HOSPITAL, BUT WAS UNABLE TO REPRODUCE THE ALLEGED FAILURE. THE DEVICE WAS RETURNED TO SPACELABS FOR FURTHER INVESTIGATION. TESTING OF THE DEVICE BY SPACELABS EQUIPMENT SERVICE CENTER (ESC) CONFIRMED IT WORKED TO SPECIFICATIONS. THE DEVICE ALARMED WHEN HEART RATE IS BELOW 40 BEATS PER MINUTE (BPM). THE HOSPITAL DID NOT PROVIDE THE TIME OF THE SUSPECTED FAILURE TO ALARM. REVIEWING WAVEFORM DATA PROVIDED BY THE HOSPITAL AND MANUALLY CALCULATING THE HEART RATE, SPACELABS DETERMINED THAT THE PATIENT'S HEART RATE DROPPED BELOW 40 BPM AS EVIDENCED ON PAGES 9 AND 10 OF THE WAVEFORM DATA. HOWEVER, THE HOSPITAL DID NOT SECURE AND PROVIDE THE ALARM SETTINGS FOR ECG ON THE MONITOR, OR THE ICS REVIEW DATA FOR ALARMS. WITHOUT SUCH INFORMATION ON THE PRODUCT SETTINGS AT THE TIME OF THE INCIDENT WE CANNOT CONFIRM A MISSED ALARM OR IDENTIFY THE ROOT CAUSE. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE IS CLOSED.

    Description of Event or Problem · 1

    DURING A RETROSPECTIVE REVIEW OF PATIENT DATA, A HOSPITAL CONCLUDED THAT A PATIENT'S HEART RATE DROPPED BELOW 40 BEATS PER MINUTE (BPM). THE HOSPITAL MADE THE DETERMINATION MEASURING DATA WITH CALIPERS IN THE INTESYS CLINICAL SUITE (ICS) SYSTEM. THE HOSPITAL HAD NO RECORD SHOWING THAT THE TELEMETRY MONITOR IN USE WITH THE PATIENT ALARMED, AND DID NOT RECALL AN ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS DIGITAL TELEMETRY TRANSMITTER TELEMETRY TRANSMITTER MHX SPACELABS MEDICAL INC 90343

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR MODEL 90478, TELEMETRY RECEIVER, SN (B)(4)