BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-1 COT - BASE HIGH LOAD 28

    MDR report key: 3082629 · Received April 29, 2013

    Report

    Report Number
    0001831750-2013-03825
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    January 10, 2013
    Report Date
    April 3, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS BEEN RETRAINED ON THE PROPER USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD END OF THE COT DROPPED TO THE GROUND. 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 HEAD END OF THE COT DROPPED TO THE GROUND. 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
    183612 M-1 COT - BASE HIGH LOAD 28 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1