BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3080 RL OPERATING ROOM TABLE

    MDR report key: 495 · Received April 8, 1992

    Report

    Report Number
    495
    Event Type
    Injury
    Date Received
    April 8, 1992
    Date of Event
    March 27, 1992
    Report Date
    March 30, 1992
    Manufacturer
    AMERICAN STERILIZAR COMPANY (AMSCO)
    Product Code
    FWW
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ORDERED AND RECEIVED 18 NEW SURGICAL TABLES FROM AMSCO. ABOUT TWO WEEKS AFTER USE, THREE TABLES DEVELOPED HYDRAULIC FLUID LEAKS. UPON INVESTIGATION BY AMSCO IT WAS DISCOVEREDD THAT SEVERAL TABLES DURING A CERTAIN PERIOD OF TIME HAD A TABLE SHAFT THAT WAS THINNER IN THE MIDDLE THEN ON THE ENDS STRETCHING THE "O" RINGS. WHEN THE "O" RINGS STRETCHED, THE HYDRAULIC FLUID LEAKS OUT AND THE TABLE BECOMES NON-OPERATIONALDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAR-92. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: OTHER, INVALID DATA. RESULTS OF EVALUATION: NONE OR UNKNOWN, INVALID DATA. CONCLUSION: DEVICE FAILED DURING ASSEMBLY. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3080 RL OPERATING ROOM TABLE 3080 RL SURGICAL TABLE FWW AMERICAN STERILIZAR COMPANY (AMSCO) BE 587283 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention