FDA Adverse Event
Malfunction
Summary report: N
COROMETRICS
MDR report key: 4963187
·
Received July 7, 2015
Report
- Report Number
- 4963187
- Event Type
- Malfunction
- Date Received
- July 7, 2015
- Date of Event
- June 30, 2015
- Report Date
- July 7, 2015
- Manufacturer
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- Product Code
- HGM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
Narratives
Description of Event or Problem · 1
PATIENT HAD A FETAL HEART MONITOR ON FOR APPROXIMATELY 5-10 MINUTES AFTER WHICH PATIENT NOTIFIED STAFF OF A STRONG SMELL OF SMOKE REPORTEDLY COMING FROM THE MACHINE. THE MACHINE WAS TURNED OFF, UNPLUGGED, AND REMOVED FROM THE ROOM. REPORTEDLY, THERE WAS NO VISIBLE SMOKE. BUILDING OPERATIONS CENTER (BOC) AND CLINICAL ENGINEERING WERE NOTIFIED TO EVALUATE THE ROOM AND EQUIPMENT. THE MANUFACTURER OF THE MONITOR WAS CONTACTED, AND THE POWER SUPPLY BOARD IS TO BE REPLACED. THERE WAS NO APPARENT PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439275 | COROMETRICS | SYSTEM, MONITORING, PERINATAL | HGM | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 259CX-C | 0034961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |