BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITOR FOR COMPARTMENTAL PRESSURE MONITORING

    MDR report key: 2823137 · Received November 7, 2012

    Report

    Report Number
    1719045-2012-01133
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXC
    PMA / PMN Number
    K031555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW REVEALED THE PART LOT WAS MADE TO CONFORMED TO SPECIFICATION REQUIREMENTS AND VERIFIED PER THE CERTIFICATE OF COMPLIANCE. THE MONITOR WAS INSPECTED AND ACCEPTED TO THE SYNTHES INSPECTION THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. A MANUFACTURING EVALUATION WAS CONDUCTED. THE DEVICE WAS RECEIVED INTACT, NO APPARENT DAMAGE. THE SUPPLIER CONDUCTED AN EVALUATION ON THE DEVICE AND DETERMINED THAT THE "CHIP WAS BADLY SOILED" AND THE "DRY-WET-TEMPERATURE DRIFT WAS BEYOND THE ACCEPTED TOLERANCE." THE DEVICE HISTORY RECORD REVIEW REVEALED THAT THE PRODUCTS WERE SHIPPED WITHIN SPECIFICATION AND PASSED ALL OF THE REQUIRED FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A COMPARTMENTAL PRESSURE MONITORING SYSTEM THAT DID NOT READ/DISPLAY AN ACCURATE MEASUREMENT. THE HEALTHCARE PROVIDER POWERED ON THE MONITOR IN ORDER TO "ZERO OUT" THE DEVICE. THE PROBE WAS THEN INSERTED INTO THE TIBIAL REGION OF THE PATIENT WHICH GAVE A READING OF 60MMHG. THE HEALTH CARE PROVIDER DETERMINED BY CLINICAL SUSPICION THAT THE READING OF 60MMHG WAS TOO HIGH AND NOT CONSISTENT WITH THE CONDITION OF THE PATIENT WHICH WAS DESCRIBED AS SOFT. AFTER REMOVING THE PROBE FROM THE PATIENT THE DEVICE DISPLAY INDICATED 30MMHG. THIS IS REPORT #1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONITOR FOR COMPARTMENTAL PRESSURE MONITORING COMPART. PRESSURE MONITOR LXC SYNTHES MONUMENT 000248

    Patients

    Seq Age Sex Outcome Treatment
    1