FDA Adverse Event
Malfunction
Summary report: N
MAQUET HCU40 DEVICE
MDR report key: 6000026
·
Received October 5, 2016
Report
- Report Number
- 8010762-2016-00605
- Event Type
- Malfunction
- Date Received
- October 5, 2016
- Date of Event
- September 8, 2016
- Report Date
- August 11, 2017
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DWC
- PMA / PMN Number
- K130300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS NO ADDITIONAL INFORMATION WERE SUBMITTED THEREFORE NO INVESTIGATION COULD BE PERFORMED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATIONS BECOMES AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE HCU40 DISPLAYED THE ERROR MESSAGE "WATER FLOW LOW". ADDITIONAL INFORMATION: THERE WERE NO PATIENT INVOLVED THE INCIDENT OCCURRED DURING CLEANING CYCLE. (B)(4).
Description of Event or Problem · 1
REF.: # (B)(4). CUSTOMER REF.: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651891 | MAQUET HCU40 DEVICE | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | DWC | MAQUET CARDIOPULMONARY AG | 701044054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |