AMSCOMATIC WASHER/STERILIZER
Received Jul 13, 1992 · Event occurred Mar 9, 1992
Report 3903 · MDR key 3903
Device
Manufacturer
Amsco/service CompanyModel number
E84WSNarrative
Description of Event or Problem
ON 3/9/92, AN EMPLOYEE IN THE CENTRAL SERVICE DEPARTMENT INJURED HER LEFT INDEX FINGER AND SUSTAINED A SECOND AND THIRD DEGREE BURNS TO HER HANDS. A BASKET BECAME CAUGHT AND THE EMPLOYEE STUCK HER HAND IN THE MACHINE AND THE DOOR CLOSED ON HER HAND. OUR INVESTIGATION REVEALED EMPLOYEE ERROR AS THE CAUSE OF THIS INCIDENTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.