FDA Adverse Event
Malfunction
Summary report: N
TERUMO CDI 540 CALIBRATOR
MDR report key: 1842233
·
Received August 27, 2010
Report
- Report Number
- 1828100-2010-01434
- Event Type
- Malfunction
- Date Received
- August 27, 2010
- Date of Event
- August 3, 2010
- Report Date
- August 27, 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
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THE AIR FILTER IN SIDE B OF THE CALIBRATOR WAS LEAKING. THIS CALIBRATOR WAS ORIGINALLY RETURNED FOR REPAIR DUE TO THE DEVICE NOT CALIBRATING WHEN THE AIR FILTER LEAK WAS FOUND. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING 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 |