BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMP PUMP TEMPERATURE

    MDR report key: 2117643 · Received May 4, 2011

    Report

    Report Number
    1313850-2011-00095
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAS NOT YET BEEN RETURNED TO MANUFACTURER FOR EVALUATION. FOLLOW-UP REPORT WILL BE FILED IF NECESSARY BASED UPON RESULTS OF MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD A MELTED CASE. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMP PUMP TEMPERATURE PUMP FOH STRYKER CORP DBA GAYMAR TP500C NA

    Patients

    Seq Age Sex Outcome Treatment
    1