MINI TELEMETRY SYSTEM

Additional Manufacturer Narrative

GE HEALTHCARE (GEHC) INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE AVAILABLE EVIDENCE, IT IS MOST LIKELY THAT THE ROOT CAUSE OF THE INCIDENT WAS USER MISUSE, WHICH LED TO WATER INGRESS INTO THE BATTERY PACK. HOWEVER, DUE TO THE LACK OF CONCLUSIVE EVIDENCE THE ROOT CAUSE REMAINS UNDETERMINED.

Additional Manufacturer Narrative

GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. G2 REPORT SOURCE OTHER: MW5167445. LEGAL MANUFACTURER: HCS INDIA WIPRO - 4, KADUGODI INDUSTRIAL AREA, INDIA BANGALORE KARNATAKA, 560067.

Description of Event or Problem

PER MEDWATCH REPORT #MW5167445: "BETWEEN 01:00 AND 01:30 OBSTETRICS DEPARTMENT STAFF HEARD A LOUD SOUND. THEY LOOKED FOR SOURCE OF THE SOUND BUT COULD NOT LOCATE THE SOURCE AND HAD TO RETURN TO THEIR DUTIES WITH A LABORING PATIENT. AT APPROXIMATELY 03:20, STAFF WENT INTO (B)(6) AND NOTED A STRONG ELECTRICAL BURN SMELL. UPON INSPECTION, STAFF DISCOVERED THAT A TELEMETRY MONITOR DEVICE WAS COVERED IN BLACK SOOT, AND SOOT ALSO COVERED SURROUNDING AREA. FIRE DEPARTMENT WAS CALLED AND CONFIRMED NO FIRE DANGER. DEVICE WAS UNPLUGGED AND ATTACHED COMPUTERS WERE POWERED DOWN. DEVICE WAS REMOVED AND SENT TO BIOMEDICAL DEPARTMENT FOR FURTHER EVALUATION AND INVESTIGATION." THE CUSTOMER FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVED AND NO PATIENT IN THE ROOM AT THE TIME OF THE EVENT.