FDA Adverse Event
Other
Summary report: N
TERUMO CDI 500 BLOOD PARAMETER MONITOR
MDR report key: 1728836
·
Received June 16, 2010
Report
- Report Number
- 1828100-2010-00572
- Event Type
- Other
- Date Received
- June 16, 2010
- Date of Event
- May 24, 2010
- Report Date
- June 16, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN FOUND THAT A PROBE ON THE DEVICE FAILED THE MANUFACTURER SELF-TEST. SINCE THIS EVENT OCCURRED AT THE SERVICE CENTER, THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO CDI 500 BLOOD PARAMETER MONITOR | ON LINE BLOOD GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 500AHCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |