FDA Adverse Event
Malfunction
Summary report: N
TERUMO CDI 500 BLOOD PARAMETER MONITOR
MDR report key: 2081891
·
Received April 5, 2011
Report
- Report Number
- 1828100-2011-00798
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 11, 2011
- Report Date
- April 5, 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 AT THE SERVICE CENTER, THE QUALITY ENGINEER REPORTED THAT THE BATTERY WOULD NOT HOLD A 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 |