BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIC CONFIGURATION MODEL 6500

    MDR report key: 2140842 · Received May 31, 2011

    Report

    Report Number
    1831750-2011-05309
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION UNDERWAY.

    Description of Event or Problem · 1

    ASB EMPLOYEE REPORTED, THAT THE HEAD PART OF THE COT IS IN MOTION ALL THE TIME. HE FURTHER REPORTED THAT THE ANTISHOCK PADS DO NOT STAND THE PRESSURE. NO FURTHER INFO WERE GIVEN. THERE WAS NO REPORTED PT INVOLVEMENT OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIC CONFIGURATION MODEL 6500 STRETCHER, WHEELED FPO STRYKER MEDICAL 6500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1