FDA Adverse Event
Other
Summary report: N
COROMETRICS MODEL 171/172 FETAL MONITOR
MDR report key: 1649783
·
Received March 31, 2010
Report
- Report Number
- 9617277-2010-00001
- Event Type
- Other
- Date Received
- March 31, 2010
- Date of Event
- February 25, 2010
- Report Date
- March 31, 2010
- Manufacturer
- WIPRO GE HEALTHCARE PRIVATE LTD.
- Product Code
- HGM
- PMA / PMN Number
- K991905
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT "A CAESAREAN SECTION WAS PERFORMED AS A RESULT OF A MISINTERPRETATION OF THE (B)(6) RECORDING." THE MONITOR WAS REPORTEDLY PRINTING AT A RATE OF 3CM/MIN, INSTEAD OF 1CM/MIN AS EXPECTED BY THE USER. PRELIMINARY TEST RESULTS REVEAL THAT THE SYSTEM IS OPERATING ACCORDING TO SPECIFICATIONS. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COROMETRICS MODEL 171/172 FETAL MONITOR | PERINATAL MONITORING SYSTEM | HGM | WIPRO GE HEALTHCARE PRIVATE LTD. | CORO 170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |