FDA Adverse Event
Malfunction
Summary report: N
TERUMO CDI 540 CALIBRATOR
MDR report key: 1973561
·
Received January 19, 2011
Report
- Report Number
- 1828100-2011-00048
- Event Type
- Malfunction
- Date Received
- January 19, 2011
- Date of Event
- November 29, 2010
- Report Date
- January 19, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
THE USER OBSERVED A "CF08" ERROR MESSAGE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO CDI 540 CALIBRATOR | CALIBRATOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |