Description of Event or Problem · 1
NEW EQUIPMENT RECEIVED 4/19/94. 133 SPECIMENS PROCESSED WITH MACHINE REPORTING ALERT THAT WAX MELTING CHAMBERS OVERHEATED. NO DAMAGE TO SPECIMENS REPORTED. ON 4/20/94, 133 SPECIMENS PROCESSED. MACHINE MALFUNCTIONED CAUSING MIX IN REAGENTS AND IMPROPER PROCESSING. REPROCESSED BY HAND ON 4/21/94. SERVICE REPRESENTATIVE ADDED NEW COMPUTER BOARD TO INSTRUMENT. TEST RAN EQUIPMENT ON 4/21/94 AND 4/22/94 WITH NO PROBLEMS. ON 4/25/94, SPECIMENS PROCESSED ON TISSUE PROCESSOR AND EQUIPMENT MALFUNCTIONED. SERVICE REPRESENTATIVE RETURNED AND FOUND A PIECE OF METAL SCRAP FLOATING THRU MACHINE CAUSING A VALVE MALFUNCTION AND CONTAMINATING CHEMICALS AND REAGENTS. TWENTY-THREE TISSUES PROCESSED. SEVENTEEN REQUIRED DISCLAIMERS ON REPORTS.INVALID 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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.