FDA Adverse Event
Other
Summary report: N
TERUMO CDI 500 BLOOD PARAMETER MONITOR
MDR report key: 2023612
·
Received January 7, 2011
Report
- Report Number
- 1828100-2010-02793
- Event Type
- Other
- Date Received
- January 7, 2011
- Date of Event
- December 13, 2010
- Report Date
- January 7, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- 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, THE USER REPORTED THE BLOOD PARAMETER MONITOR FAILED THE STANDARD REFERENCE SENSOR SOFTWARE TESTING. NO OTHER DETAILS REGARDING THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
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 |