FDA Adverse Event
Other
Summary report: N
PARATREND 7+ SENSOR
MDR report key: 340701
·
Received July 3, 2001
Report
- Report Number
- 9612233-2001-00017
- 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 DIAMETRICS MEDICAL LIMITED (DML) FROM ITS JAPANESE DISTRIBUTOR - BAYER MEDICAL LIMITED. THE SENSOR HAD BEEN RETURNED FROM HOSPITAL, FOR ROUTINE INVESTIGATION OF A REPORTED 'SENSOR MALFUNCTION' DURING INSERTION. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY TO THE PT. IT WAS ONLY WHEN THE INVESTIGATION BEGAN THAT IT WAS SEEN THAT THE SENSOR WAS DAMAGED AND A DECISION TO REPORT WAS MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30102 | PARATREND 7+ SENSOR | BLOOD GAS MONITORING SYSTEM | CCE | DIAMETRICS MEDICAL, LTD. | MPS 7004 P | 766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |