FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1022450
·
Received March 26, 2008
Report
- Report Number
- 1828100-2008-00161
- Event Type
- Malfunction
- Date Received
- March 26, 2008
- Date of Event
- February 25, 2008
- Report Date
- March 26, 2008
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS BUT NOT CONCLUDED.
Description of Event or Problem · 1
DURING MAINTENANCE OF THE DEVICE, THE RECOMMENDED TEST OF THE BACKUP BATTERIES WAS PERFORMED. THE USER OBSERVED THAT THE BACKUP BATTERIES DID NOT HOLD ENOUGH CHARGE TO OPERATE THE DEVICE AS EXPECTED. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | HEART LUNG CONSOLE (BATTERY) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 145955 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |