BEUDAMED
    FDA Adverse Event Other Summary report: N

    IN TOUCH ZU

    MDR report key: 2275485 · Received September 6, 2011

    Report

    Report Number
    1831750-2011-09467
    Event Type
    Other
    Date Received
    September 6, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 9, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS REPORT IS TO NOTIFY STRYKER THAT THERE ARE NUMEROUS BEDS WITH THE PINS PUSHED DOWN ON THE FOOTBOARD. NO SPECIFIC BED WAS IDENTIFIED, NO SERIAL NUMBERS GIVEN, NOR A QUANTITY OF BEDS AFFECTED. THE FIELD TECHNICIAN WILL INVESTIGATE THE ISSUE AND ANY BEDS THAT ARE REPAIRED WILL BE DOCUMENTED IN SEPARATE MDRS IF REQUIRED BY 21 CFR PART 803.

    Description of Event or Problem · 1

    THE CUSTOMER NOTIFIED IN THIS REPORT THAT ALLEGEDLY THE PINS BECAME "PUSHED DOWN" ON THE FOOTBOARDS ON ALMOST ALL OF THEIR INTOUCH MODEL BEDS. NO SPECIFIC SERIAL NUMBERS WERE GIVEN NOR A QUANTITY. THE ISSUE WILL BE INVESTIGATED AND ANY BEDS THAT ARE REPAIRED WILL BE DOCUMENTED IN SEPARATE MDRS IF THEY MEET THE REQUIREMENTS AS CITED IN 21 CFR PART 803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN TOUCH ZU A/C HOSPITAL BED FNL STRYKER MEDICAL 2141 NA

    Patients

    Seq Age Sex Outcome Treatment
    1