BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT XG

    MDR report key: 818136 · Received November 10, 2004

    Report

    Report Number
    2221819-2004-00043
    Event Type
    Malfunction
    Date Received
    November 10, 2004
    Date of Event
    October 7, 2004
    Report Date
    October 8, 2004
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONITOR WAS RETURNED TO THE FACTORY FOR EVALUATION. DATASCOPE'S NATIONAL REPAIR CENTER DETERMINED THAT THE POWER SUPPLY (0014-00-0028), AND LINE BATTERY BOARD (0670-00-0656) HAD EVIDENCE OF HEAT-RELATED DAMAGE. DURING A CONVERSATION WITH CANDY BECK OF DATASCOPE QUALITY ENGINEERING, ON NOVEMBER 4, REP OF C & D TECHNOLOGIES (THE POWER SUPPLY VENDOR) ADVISED THAT THERE ARE NO HAZARDOUS CHEMICALS IN THE POWER SUPPLY, AND THERE IS NO DANGER OF HAZARDS FROM THE SMOKE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE, MONITORING A PATIENT, THE MONITOR EMITTED SMOKE FROM THE FRONT PANEL. THE MONITOR WAS DISCONNECTED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED. TWO HEALTH CARE PRACTITIONERS WHO CAME INTO CONTACT WITH THE SMOKE REPORTED EXPERIENCING HEADACHE (DIRECTOR OF NURSING) AND COUGHING (ADMINISTRATOR) AFTER INHALING THE SMOKE. REPORTER STATED THAT SHE HAD EXPERIENCED A BURNING SENSATION IN HER RESPIRATORY TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSPORT XG PHYSIOLOGICAL MONITOR MHX DATASCOPE CORPORATION PASSPORT XG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR