FDA Adverse Event
Malfunction
Summary report: N
MAQUET CARDIOPULMONARY AG
MDR report key: 3894138
·
Received February 6, 2014
Report
- Report Number
- 8010762-2014-00043
- Event Type
- Malfunction
- Date Received
- February 6, 2014
- Date of Event
- January 7, 2014
- Report Date
- January 8, 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
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A MAQUET SERVICE TECHNICIAN WAS ABLE TO VERIFY THE INCIDENT. THE DEFECTIVE CONTROL BOARD WAS REPLACED. THE SYSTEM WAS TESTED TO FACTORY SPECIFICATIONS AND PASSED. THE UNIT WAS RETURNED TO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LPM WOULD FLUCTUATE DURING THE INITIAL SET-UP OF THE HL20. INTERNAL REFERENCE: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78661 | MAQUET CARDIOPULMONARY AG | HL 20 5-PUMPS CONSOLE BASE | DTQ | MAQUET CARDIOPULMONARY AG | 701027652 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |