BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 2981239 · Received February 27, 2013

    Report

    Report Number
    0001831750-2013-01558
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE BED DID NOT HAVE UNINTENDED MOTION BUT SEEMED UNBALANCED DUE TO A LARGE AMOUNT OF WEIGHT PLACED AT THE HEADEND OF THE BED. NO DEFECT WAS FOUND AND THE BED WAS WORKING TO SPECIFICATION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED HAS UNINTENDED MOVEMENT WHEN THE PATIENT IS LYING ON IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED HAS UNINTENDED MOVEMENT WHEN THE PATIENT IS LYING ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83860 LD304 MATERNITY BED TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) HDD STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1