BEUDAMED
    FDA Adverse Event Other Summary report: N

    PASSPORT 2

    MDR report key: 756579 · Received August 30, 2006

    Report

    Report Number
    2221819-2006-00061
    Event Type
    Other
    Date Received
    August 30, 2006
    Date of Event
    August 1, 2006
    Report Date
    August 2, 2006
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONITOR WAS RETURNED TO DATASCOPE FOR EVALUATION. IT SUSTAINED SIGNIFICANT DAMAGE AS A RESULT OF THE REPORTED FIRE AND SMOKE, INCLUDING THREE CAPACITORS WHICH APPEAR MELTED ON THE CO2 BOARD (LIKELY THE SOURCE OF THE "POPPING" SOUND THE BIOMED HEARD). IT IS IMPORTANT TO NOTE THAT THE PASSPORT 2 SERVICE MANUAL (SECTION 3.6 DISASSEMBLY INSTRUCTIONS) INSTRUCTS THE USER TO REMOVE THE BATTERIES BEFORE DISASSEMBLING THE MONITOR. THE BIOMED DID NOT FOLLOW THIS INSTRUCTION. HE SAID HIS USUAL PRACTICE IS TO REMOVE THE POWER SUPPLY PRIOR TO ATTEMPTING ANY REPAIR. DATASCOPE QUALITY ENGINEERING REVIEWED THE DISASSEMBLY INSTRUCTIONS WITH THE CUSTOMER, EMPHASIZING THAT THE BATTERIES MUST BE REMOVED PRIOR TO SERVICING, AND THE POWER SUPPLY DOES NOT HAVE TO BE REMOVED PRIOR TO OPENING THE UNIT. DATASCOPE HAS NOT RECEIVED ANY RELATED REPORTS. THIS FAULT WAS CAUSED BY USER ERROR. DATASCOPE IS CLOSING ITS INCIDENT ON THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ADVISED DATASCOPE QUALITY ENGINEERING THAT THE MONITOR CAUGHT FIRE WHEN THE BIOMED TOOK IT APART FOR SERVICE. THE LINE CORD WAS NOT IN THE UNIT, BUT THE BATTERIES WERE. THE BIOMED SAID THAT HE OPENED THE POWER SUPPLY COVER AND REMOVED THE FOUR SCREWS SECURING THE POWER SUPPLY, THEN PULLED THE POWER SUPPLY FROM THE MONITOR ASSEMBLY. HE THEN REACHED AROUND TO THE BACK OF THE UNIT TO OPEN THE ENCLOSURE, AND FELT THAT THE UNIT WAS VERY HOT. AT THIS POINT, HE REMOVED THE BATTERIES. HE HEARD A POP LIKE A CAPACITOR, AND THEN SAW FLAMES AND LOTS OF SMOKE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSPORT 2 PHYSIOLOGICAL MONITOR MHX DATASCOPE CORPORATION PASSPORT 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA