FDA Adverse Event
Other
Summary report: N
PARATREND 7+ SENSOR
MDR report key: 340758
·
Received July 3, 2001
Report
- Report Number
- 9612233-2001-00018
- Event Type
- Other
- Date Received
- July 3, 2001
- Date of Event
- January 1, 2001
- Report Date
- May 18, 2001
- Manufacturer
- DIAMETRICS MEDICAL, LTD.
- Product Code
- CCE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A PARATREND 7+ SENSOR WAS RETURNED TO DIAMTRICS MEDICAL LIMITED FROM ITS JAPANESE DISTRIBUTOR - BAYER MEDICAL LIMITED. THIS SENSOR HAD BEEN RETURNED FROM HOSP FOR ROUTINE INVESTIGATION INTO A REPORTED MALFUNCTION. IT WAS ONLY WHEN INVESTIGATION COMMENCED AT DIAMETRICS MEDICAL LTD THAT A SECONDARY ISSUE OF CRACKS IN THE PRESSURE MONITORING PORT WAS SEEN AND A DECISION TO REPORT WAS MADE. THERE WAS NO REPORT FROM THE CUSTOMER OF ANY ADVERSE EVENT OR PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30525 | PARATREND 7+ SENSOR | BLOOD GAS MONITORING SYSTEM | CCE | DIAMETRICS MEDICAL, LTD. | MPS 7004P | 766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |