FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2785155
·
Received October 9, 2012
Report
- Report Number
- 1828100-2012-01301
- Event Type
- Malfunction
- Date Received
- October 9, 2012
- Date of Event
- September 11, 2012
- Report Date
- September 11, 2012
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE QUALITY ENGINEER AT THE MFG ENGINEERING CENTER (MEC) COULD DUPLICATE THE REPORTED ISSUE. EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
THE SERVICE REPAIR TECHNICIAN REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THAT A CALIBRATION ERROR OCCURRED (CODE: 23 4023) ON THE ELECTRONIC PATIENT GAS SYSTEM (EPGS). THIS IS A DEMO UNIT AT THE MFG ENGINEERING CENTER (MEC). THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |