FDA Adverse Event
Malfunction
Summary report: N
MAQUET HCU20
MDR report key: 4240038
·
Received November 3, 2014
Report
- Report Number
- 8010762-2014-01098
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- October 4, 2014
- Report Date
- October 4, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DWC
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A MAQUET SERVICE TECH INVESTIGATED THE DEVICE AND FOUND THE FAILURE WITH TANK PT (B)(4). THE PT (B)(4) WAS REPLACED AND THE UNIT WAS TESTED TO FACTORY SPECS. DEVICE WAS RETURNED TO SERVICE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT START-UP, THE DEVICE DISPLAYED TANK TEMPERATURE UNK VALUES. DISPLAY SHOWED COMP ERROR. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703495 | MAQUET HCU20 | CONTROLLER, TEMP, CARDIOPULMONARY BYPASS | DWC | MAQUET CARDIOPULMONARY AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |