FDA Adverse Event
Malfunction
Summary report: N
MAQUET CARDIOPULMONARY AG
MDR report key: 3941699
·
Received March 5, 2014
Report
- Report Number
- 8010762-2014-00109
- Event Type
- Malfunction
- Date Received
- March 5, 2014
- Date of Event
- January 23, 2014
- Report Date
- January 23, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- K943803
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDE PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A MAQUET SERVICE TECHNICIAN CHANGED THE SAFETY BOARD AND TESTED THE SYSTEM. THE SYSTEM PASSED TESTING. THE UNIT WAS RETURNED TO SERVICE. THE SAFETY BOARD HAS BEEN REQUESTED FOR EVALUATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE INSTALLATION OF A HEART LUNG MACHINE AND DURING SYSTEM TESTING, ONE PUMP DISPLAYED AN ERROR MESSAGE STATING THE SAFETY SYSTEM HAD DISCOVERED A DEVIATION FROM SET VALUES. INTERNAL REFERENCE: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132725 | MAQUET CARDIOPULMONARY AG | HL 20 CONSOLE BASE | DTQ | MAQUET CARDIOPULMONARY AG | NI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |