BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-PARAMETER MONITOR; DOMESTIC; W WAVEFORM; I

    MDR report key: 2270692 · Received September 14, 2011

    Report

    Report Number
    8010219-2011-00019
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    July 30, 2011
    Report Date
    September 14, 2011
    Manufacturer
    INTEGRA, ANDOVER
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "A RETROSPECTIVE QUALITY REVIEW OF THIS RECORD DEEMED A SUBSEQUENT REPORT SHOULD HAVE BEEN FILED." AN INITIAL MDR MFR REPORT # 8010219-2011-00013 (B)(4) WAS FILED ON (B)(4) 2011. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    SECOND REPORT OF THREE INVOLVING A CAMINO MONITOR THAT DID NOT FUNCTION. CROSS REFERENCE WITH MFR. # 8010219-2011-00013 (B)(4). A PT WITH A SEVERE HEAD TRAUMA FOLLOWING A ROAD TRAFFIC ACCIDENT, WAS ADMITTED TO THE INTENSIVE CARE DEPARTMENT AND WAS IN NEED OF MONITORING WITH A CAMINO MONITOR. AFTER TRYING THREE DIFFERENT MONITORS AND CABLES, THE HOSPITAL STAFF COULD NOT GET ANY OF THE MONITORS TO WORK PROPERLY. ULTIMATELY ANOTHER CAMINO MONITOR HAD TO BE REMOVED FROM ANOTHER PT IN INTENSIVE CARE SO THAT THEY COULD MONITOR THE NEWLY ARRIVED PT. THE STAFF THEN HAD TO REQUEST A CAMINO MONITOR FROM ANOTHER FACILITY TO BE TRANSFERRED TO THE HOSPITAL SO THEY COULD CONTINUE MONITORING THE OTHER PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-PARAMETER MONITOR; DOMESTIC; W WAVEFORM; I NA GWM INTEGRA, ANDOVER

    Patients

    Seq Age Sex Outcome Treatment
    1