FDA Adverse Event
Malfunction
Summary report: N
TERUMO CDI 500 BLOOD PARAMETER MONITOR
MDR report key: 2021831
·
Received February 25, 2011
Report
- Report Number
- 1828100-2011-00423
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 25, 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
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICAL REPORTED THAT THE 12 VOLT BATTERY WOULD NOT CHARGE. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PT 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 |