FDA Adverse Event
Malfunction
Summary report: N
MAQUET CARDIOPULMONARY AG
MDR report key: 3853425
·
Received April 4, 2014
Report
- Report Number
- 8010762-2014-00174
- Event Type
- Malfunction
- Date Received
- April 4, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 5, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A MAQUET SERVICE TECHNICIAN EVALUATED THE DEVICE AND FOUND A FAULTY MOTOR CONTROL BOARD. THE MOTOR CONTROL BOARD WAS REPLACED. FUNCTIONAL AND SAFETY TESTING WAS SUCCESSFULLY EXECUTED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP ON THE DEVICE DISPLAYED AN ERROR MESSAGE, REV_REL (FAULTY REVERSE RELAY. THERE WAS NO PATIENT INVOLVEMENT. REFERENCE: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204840 | MAQUET CARDIOPULMONARY AG | HL 20 CONSOLE BASE | DTQ | MAQUET CARDIOPULMONARY AG | MCP00703317 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |