BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYE SURGERY STRETCHER OBS 3/07

    MDR report key: 2944488 · Received February 5, 2013

    Report

    Report Number
    0001831750-2013-00778
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE STRYKER TECHNICIAN THAT THE CUSTOMER ALLEGED THAT A NURSE WAS MOVING TO LOWER THE FOWLER WHEN THE FOWLER DROPPED. THE CUSTOMER ALSO ALLEGED THAT A NURSE'S HAND WAS UNDERNEATH AND THE NURSE STRAINED HER SHOULDER. HOWEVER, NO MEDICAL INTERVENTION WAS REPORTED FOR THE STRAIN. THE NURSING STAFF DID NOT KNOW HOW IT OCCURRED AND WERE NOT ABLE TO DUPLICATE THE EVENT. THE STRYKER TECHNICIAN EVALUATED THE UNIT AND COULD NOT FIND A DEFECT AND COULD NOT DUPLICATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE FOWLER WOULD DROP DOWN UNINTENTIONALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE FOWLER WOULD DROP DOWN UNINTENTIONALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47915 EYE SURGERY STRETCHER OBS 3/07 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1069

    Patients

    Seq Age Sex Outcome Treatment
    1