BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 3152525 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01227
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE COUNTER IS AT MAX AND CANNOT BE CLEARED. THIS IS EXPECTED BEHAVIOR.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC MONITOR HAS AN ASYSTOLE COUNTER THAT IS STUCK AT THE MAX VALUE AND NO DATA IS THERE. THE DEVICE WILL ALLOW CLEARING THIS COUNTER, BUT ON RE-INTERROGATION THIS NUMBER APPEARS AGAIN, AND AGAIN WITH NO DATA. IT WAS ALSO REPORTED THAT THE DEVICE CANNOT COLLECT AUTO DATA, BUT IS OK FOR PATIENT ACTIVATED. THE DEVICE REMAINS IN USE. THE PATIENT WAS REPORTEDLY SYMPTOMATIC BUT NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253079 REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND 9528

    Patients

    Seq Age Sex Outcome Treatment
    1