BEUDAMED
    FDA Adverse Event Other Summary report: N

    970SE SMART MONITOR

    MDR report key: 873063 · Received June 29, 2007

    Report

    Report Number
    2518422-2007-00058
    Event Type
    Other
    Date Received
    June 29, 2007
    Date of Event
    April 1, 2006
    Report Date
    June 7, 2007
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT ALLEGES A FAULTY DEVICE CONTRIBUTED TO THE DEATH OF A PT. THE ALLEGED EVENT REPORTEDLY OCCURRED DURING 2006, THE EXACT DATE IS NOT KNOWN AT THIS TIME. THE NATURE OF THE ALLEGED DEVICE MALFUNCTION IS UNK AT THIS TIME. THE DEVICE REPORTEDLY SAT ON A SHELF IN A POLICE DEPT FOR AN EXTENDED TIME WITHOUT BEING PLUGGED INTO AN ELECTRICAL OUTLET. AFTER CHARGING THE DEVICE, THE CUSTOMER PERFORMED A MEMORY DOWNLOAD AND THE OUTPUT READ "NO WAVEFORM AVAILABLE". THE DEVICE WAS RETURNED TO THE MFR FOR EVAL AND MEMORY DOWNLOAD. WHEN THE DOWN LOAD WAS ATTEMPTED, IT APPEARED THAT THE DEVICE MEMORY MAY HAVE CLEARED OR LOST DUE TO A DEPLETED BATTERY. AN EVALUATION WAS PERFORMED AND THE DEVICE WAS FOUND TO OPERATE AND ALARM TO SPECIFICATION. NO ADD'L INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 970SE SMART MONITOR INFANT APNEA MONITOR BZQ RESPIRONICS INC. 970SE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death OHMEDA TRUE SAT PULSE OXIMETER