Description of Event or Problem · 1
PLANNED VAGINAL BREACH DELIVERY OF 19 YEAR OLD FEMALE. ATTEMPT TO APPLY FETAL SCALP ELECTRODES TO BUTTOCKS; NO TRACING ON MONITOR. ELECTRODES REAPPLIED; NO SIGNAL. BABY DELIVERED, ADMITTED TO NICU, DISCHARGED HOME AT ELEVEN DAYS. EVALUATION OF MONITOR REVEALED FAULTY EKG CIRCUIT BOARD. BAYSTATE MEDICAL CENTER SUBMITS THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS REPORT IS BASED ON PRELIMINARY INFORMATION RECEIVED BY BAYSTATE MEDICAL CENTER WHICH BAYSTATE MEDICAL CENTER HAS NOT HAD THE OPPORTUNITY TO INVESTIGATE OR VERIFY PRIOR TO THE REPORTING DATE. BAYSTATE MEDICAL CENTER HAS NOT CONCLUSIVELY DETERMINED THE CAUSE OF THIS EVENT. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY BAYSTATE MEDICAL CENTER THAT IT OR ANY OF ITS EMPLOYEES OR AFFILIATES CAUSED OR CONTRIBUTED TO THE INCIDENT DESCRIBED HEREIN. IN ADDITION, THE SUBMISSION OF THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAY-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: EKG/ECG SUBASSEMBLY. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.