BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_MEDICAL_PRODUCT

    MDR report key: 3833142 · Received May 27, 2014

    Report

    Report Number
    0001831750-2014-03016
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS REPORTED INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE MANUFACTURER. THE MANUFACTURER FOR THE PRODUCT WAS IDENTIFIED AND A LETTER HAS BEEN SENT TO THE FOOD AND DRUG ADMINISTRATION INFORMING THEM OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WOULD NOT ENGAGE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WOULD NOT ENGAGE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311214 UNKNOWN_MEDICAL_PRODUCT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1