BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMP PUMP TEMPERATURE

    MDR report key: 2043599 · Received March 29, 2011

    Report

    Report Number
    1313850-2011-00052
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 1, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THIS WAS A RENTAL UNIT AND IT WAS REPLACED FOR THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BURN EVIDENCE WAS FOUND ALONG A TRACE ON THE PRINTED CIRCUIT BOARD. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMP PUMP TEMPERATURE PUMP ILO STRYKER CORP DBA GAYMAR TP500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1