BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AE LAL CONTROL UNIT

    MDR report key: 2891300 · Received November 29, 2012

    Report

    Report Number
    1313850-2012-00366
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 5, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT SOMETHING ROLLED OVER THE POWER CORD CAUSING DAMAGE TO THE UNIT. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AE LAL CONTROL UNIT LOW AIR LOSS CONTROL UNIT FNM STRYKER CORP DBA GAYMAR C1500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1