BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE FOR CPMS

    MDR report key: 3770831 · Received April 24, 2014

    Report

    Report Number
    2520274-2014-10911
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 28, 2014
    Manufacturer
    N/I
    Product Code
    LXC
    PMA / PMN Number
    PK031555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE MANUFACTURER CITY WAS INADVERTENTLY DOCUMENTED AS DEPUY SYNTHES POWER TOOLS. THIS PRODUCT PROBE FOR CPMS IS NOT MANUFACTURED BY DEPUY SYNTHES AND IS MANUFACTURED BY: MIPM. ALL FURTHER INVESTIGATION WILL BE PERFORMED BY MIPM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER¿S PHONE NUMBER: (B)(6). THE MANUFACTURER¿S INFORMATION WAS UNKNOWN. DEVICE MANUFACTURE DATE WAS UNKNOWN. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING A COMPARTMENTAL PRESSURE MONITORING SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE PROBE DEVICE DISPLAYED AN ¿ERROR CODE¿. ACCORDING TO THE REPORTER, THE PROCEDURE WAS BEING PERFORMED TO DETERMINE IF SURGERY WAS AN OPTION FOR CHRONIC EXERTIONAL COMPARTMENT SYNDROME. THERE WAS A TWENTY FIVE MINUTE DELAY TO THE PLANNED SURGICAL PROCEDURE. AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249222 PROBE FOR CPMS MONITOR, PRESSURE, INTRACOMPARTMENT LXC N/I 25-1585

    Patients

    Seq Age Sex Outcome Treatment
    1