BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-1 COT - BASE HIGH LOAD 28

    MDR report key: 3013490 · Received March 20, 2013

    Report

    Report Number
    0001831750-2013-02243
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    May 25, 2012
    Report Date
    February 20, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): SERVICED BY (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS INITIALLY REPORTED AS 6100-031-000, SERIAL NUMBER (B)(4) WHICH WAS INCORRECT. THE CORRECT PRODUCT IS 6100-003-000, SERIAL NUMBER UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT DROPPED AT THE HEAD END. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT DROPPED AT THE HEAD END. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115308 M-1 COT - BASE HIGH LOAD 28 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1