BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 2962456 · Received February 14, 2013

    Report

    Report Number
    0001831750-2013-01185
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH CORRECTED SERIAL NUMBER.

    Additional Manufacturer Narrative · 1

    CPR BALL SCREW. RESULT- FOWLER LINK BRACKET. CLEVIS PIN.

    Additional Manufacturer Narrative · 1

    THIS WAS INADVERTENTLY REPORTED AS A DEATH IN THE OUTCOME ATTRIBUTED TO AE FIELD OF THE INITIAL MDR. SECOND FOLLOW-UP SUBMITTED TO CORRECT THIS AS THERE WAS NO PATIENT INVOLVEMENT OR DEATH REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER WOULD NOT LAY FLAT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER WOULD NOT LAY FLAT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER WOULD NOT LAY FLAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65775 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death