FDA Adverse Event
Other
Summary report: N
TERUMO CDI 500 BLOOD PARAMETER MONITOR
MDR report key: 1891646
·
Received October 13, 2010
Report
- Report Number
- 1828100-2010-01819
- Event Type
- Other
- Date Received
- October 13, 2010
- Date of Event
- June 24, 2010
- Report Date
- October 13, 2010
- 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 USER REPORTED, THE MONITOR DISPLAYED BOTH "F133" AND "F233" ERROR CODES UPON START UP. THE MONITOR WAS ORIGINALLY RETURNED FOR REPAIR OF AN ARTERIAL STANDARD REFERENCE SENSOR FOR FAILURE WHEN THE ERROR CODES WERE FOUND. 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 |