FDA Adverse Event Malfunction Summary report: N

3080 RC TABLE

MDR report key: 1223 · Received August 27, 1992

Report

Report Number
1223
Event Type
Malfunction
Date Received
August 27, 1992
Date of Event
August 5, 1992
Report Date
August 13, 1992
Manufacturer
AMSCO
Product Code
FWW
Product Problem
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

FOLLOWING LAST CASE OF DAY. NURSING STAFF NOTED AMBER COLOR LIQUID ON THE FLOOR BENEATH THE OR TABLE. AMSCO SERVICE REPRESENTATIVE NOTIFIED. SALES REP. REPORTED HYDRAULIC HOSE SUPPORT POST HOLE TAPPED THROUGH TABLE BASE,- ALLOWING ANY OIL IN BASE TO RUN OUT ONTO FLOORDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAY-92. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 3080 RC TABLE OR TABLE FWW AMSCO 3080 RC

Patients

Seq Age Sex Outcome Treatment
1 Other