FDA Adverse Event
Injury
Summary report: N
MAQUET CARDIOPULMONARY AG
MDR report key: 3953165
·
Received June 20, 2014
Report
- Report Number
- 8010762-2014-00244
- Event Type
- Injury
- Date Received
- June 20, 2014
- Date of Event
- May 21, 2014
- Report Date
- May 22, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A MAQUET FIELD SERVICE TECH EVALUATED THE DEVICE AND DETERMINED THE CONTROL BOARD AND HEAD WERE DEFECTIVE. THE CONTROL BOARD AND HEAD WERE REPLACED. THEY SYSTEM WAS SUCCESSFULLY TESTED TO FACTORY SPECIFICATIONS AND RETURNED TO SERVICE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. REF EXEMPTION #: (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD DISPLAY A RUN-AWAY ERROR ON THE SCREEN WHILE BEING USED ON A PT. THE DEVICE WAS EXCHANGED FOR ANOTHER. NO REPORTED PT EFFECT. REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 363541 | MAQUET CARDIOPULMONARY AG | ROTAFLOW CONSOLE | KFM | MAQUET CARDIOPULMONARY AG | MCP0.0702697 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |