FDA Adverse Event
Malfunction
Summary report: N
TERUMO CDI 540 CALIBRATOR
MDR report key: 2062323
·
Received April 12, 2011
Report
- Report Number
- 1828100-2011-00907
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 18, 2011
- Report Date
- April 12, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTY
- 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
UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT MIXED GAS A/D WAS TOO LOW (19 INSTEAD OF MINIMAL 21). THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO CDI 540 CALIBRATOR | CALIBRATOR | DTY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 151802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |