BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIC CONFIGURATION MODEL 6100 BASE

    MDR report key: 1982305 · Received January 13, 2011

    Report

    Report Number
    1831750-2011-00469
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 16, 2010
    Manufacturer
    STRYKER CORP, MEDICAL DIV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MR. (B)(6) REPORTED IN HIS LETTER THAT THE COT WAS LOWERED DOWN THE HALF WITH THE PATIENT ON THIS. AFTER APPROXIMATELY TWO MINUTES THE HEADEND IS CRASHED TO DOWN. FURTHER HE ALLEGED THAT AN INADVERTENTLY TRIGGERING IS EXCLUDED. THE COT WAS NO LONGER OPERATIONAL AFTER THAT. THE COMPANY (B)(4) REPAIRED THE COT. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIC CONFIGURATION MODEL 6100 BASE STRETCHER, WHEELED FPO STRYKER CORP, MEDICAL DIV 6100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1