FDA Adverse Event
Malfunction
Summary report: N
MAQUET HCU30 DEVICE
MDR report key: 4113697
·
Received September 17, 2014
Report
- Report Number
- 8010762-2014-00332
- Event Type
- Malfunction
- Date Received
- September 17, 2014
- Date of Event
- August 20, 2014
- Report Date
- August 21, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DWC
- PMA / PMN Number
- K031544
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A SERVICE ORDER HAS BEEN DISPATCHED TO A MAQUET FIELD SERVICE TECHNICIAN. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT WOULD NOT MAINTAIN A BLOCK OF ICE DURING A CASE. THE DEVICE WAS NOT CHANGED OUT. NO REPORTED PATIENT EFFECT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 575667 | MAQUET HCU30 DEVICE | HCU 30 BASE UNIT 200-240 V | DWC | MAQUET CARDIOPULMONARY AG | MCP00704629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 MO |