FDA Adverse Event
Injury
Summary report: N
MCP00703159#RFC 20-970 ROTA FLOW CONSOLE
MDR report key: 4821491
·
Received June 4, 2015
Report
- Report Number
- 8010762-2015-00682
- Event Type
- Injury
- Date Received
- June 4, 2015
- Report Date
- August 14, 2015
- Manufacturer
- MAQUETCARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- K991864
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEVICE WILL INVESTIGATED BY A MAQUET SERVICE TECHNICIAN. A SUPPLEMENTAL - MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS EVALUATED BY A MAQUET SERVICE TECHNICIAN WHO CONFIRMED THE REPORTED PROBLEM AND REPLACED THE CONTROL BOARD. THE DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS.
Description of Event or Problem · 1
(B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361559 | MCP00703159#RFC 20-970 ROTA FLOW CONSOLE | DTQ | MAQUETCARDIOPULMONARY AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |