BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER PRO AMBULANCE COT

    MDR report key: 3011334 · Received March 19, 2013

    Report

    Report Number
    0001831750-2013-02214
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS ORIGINALLY REPORTED AS A COT TIP WITH NO CONFIRMED INJURY TO THE PATIENT. AFTER SPEAKING WITH THE CUSTOMER IT IS ALLEGED THAT THE COT DROPPED WITH A PATIENT STRAPPED TO THE COT. THE PATIENT ALLEGEDLY RECEIVED A BROKEN VERTEBRAE AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT TIPPED WITH A PATIENT ON IT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. UPON EVALUATION BY A SERVICE TECHNICIAN NO DEFECT WAS FOUND AND THE COT WAS FOUND TO BE PERFORMING TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE COT DROPPED WITH A PATIENT STRAPPED TO THE COT. THE PATIENT ALLEGED AN INJURY AS A RESULT OF THE DROP. THE PATIENT ALLEGED THAT THEY HAD FRACTURED THEIR VERTEBRAE DUE TO THE DROP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113726 POWER PRO AMBULANCE COT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1