FDA Adverse Event
Malfunction
Summary report: N
MAQUET HCU30 DEVICE
MDR report key: 3941672
·
Received March 5, 2014
Report
- Report Number
- 8010762-2014-00110
- Event Type
- Malfunction
- Date Received
- March 5, 2014
- Date of Event
- January 30, 2014
- Report Date
- February 5, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DWC
- PMA / PMN Number
- NI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- BIOMEDICAL ENGINEER
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. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A HCU30 DEVICE WAS USED DURING AN ARCH REPLACEMENT PROCEDURE. THE DEVICE WATER TEMPERATURE WAS SET TO 20 DEGREES CENTIGRADE, THEN CHANGED TO 37 DEGREES CENTIGRADE FOR THE PROCEDURE. AFTER A WHILE, AN ALARM WITH ERROR CODE NUMBER 1004-2 WAS CREATED. THE DEVICE PERFORMED NORMALLY WHEN RE-BOOTED, BUT AN ALARM WAS GENERATED. THE ERROR WAS REPEATED THREE TIMES AND THE DEVICE WAS RE-BOOTED THREE TIMES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY REPORTED. REFERENCE: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132381 | MAQUET HCU30 DEVICE | HCU30 200V-240V | DWC | MAQUET CARDIOPULMONARY AG | 70102.8718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |