CARDIAC CHAIR
Received Aug 18, 1992 · Event occurred May 2, 1992
Report 1130 · MDR key 1130
Device
Generic name
Cardiac Chair
Manufacturer
TempcoNarrative
Description of Event or Problem
NURSING ASSISTANT WAS MOVING TABLE ATTACHED TO CARDIAC CHAIR. 5TH DIGIT, LEFT HAND ENTERED SMALL OPOENING BETWEEN TABLE AND CHAIR-RAIL, FINGER LACERATED REQUIRING (6) SIX SUTURESDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS. CONCLUSION: USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.