BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HILL ROM

    MDR report key: 3953 · Received August 28, 1992

    Report

    Report Number
    3953
    Event Type
    Malfunction
    Date Received
    August 28, 1992
    Date of Event
    April 5, 1992
    Report Date
    July 28, 1992
    Manufacturer
    HILL ROM
    Product Code
    IYZ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    MALE PATIENT, 84 YEARS OF AGE, RECEIVED SMALL CUT ON LATERAL SIDE OF 4TH FINGER AS A RESULT OF CONTACT WITH AN OVER BED TABLE MECHANISM (TABLE ASSET #05242). TABLE SLIDE, HILL ROM PART #624-631 WAS OBSERVED TO HAVE SHARP END AND EDGES, WHICH APPARENTLY INFLICTED THE INJURY, WOULD WAS TREATED WITH ANTI-SEPTIC AND COVERED, PHYSICIAN WAS NOTIFIED AND NO FURTHER TREATMENT OR FOLLOW-UP WAS RECOMMENDED. OVER-BED TABLE WAS TAGGED AND SENT TO MAINTENANCE FOR REPAIR. MAINTENANCE TECHNICIANSREPORTED FILING SEVERAL SHARP EDGES OFF SLIDE MECHANISMS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: MANUFACTURING. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HILL ROM OVER BED TABLE IYZ HILL ROM 631-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other