FDA Adverse Event
Injury
Summary report: N
MAQUET CARDIOPULMONARY AG
MDR report key: 3738062
·
Received March 28, 2014
Report
- Report Number
- 8010762-2014-00166
- Event Type
- Injury
- Date Received
- March 28, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- K991864
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A MAQUET SERVICE TECHNICIAN EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE ISSUE. THE SERVICE TECHNICIAN CONFIRMED THE BATTERY WAS AT FULL CHARGE PRIOR TO PERFORMING THE BATTERY RUN TIME TEST AND VERIFIED THE RUN TIME EXCEEDED MORE THAN 90 MINUTES. COMPLETE PERFORMANCE AND FUNCTIONAL TESTING WAS SUCCESSFULLY EXECUTED. THE DEVICE WAS CLEARED FOR CLINICAL USE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
REF IMP REPORT NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186312 | MAQUET CARDIOPULMONARY AG | ROTAFLOW CONSOLE | DTQ | MAQUET CARDIOPULMONARY AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |