FDA Adverse Event
Malfunction
Summary report: N
TERUMO CDI 500 BLOOD PARAMETER MONITOR
MDR report key: 2210280
·
Received August 8, 2011
Report
- Report Number
- 1828100-2011-02361
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- July 15, 2011
- Report Date
- August 8, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
THE USER REPORTED THAT THE MONITOR GENERATED ERROR CODES UPON POWER UP. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE REPORTED.
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 |