FDA Adverse Event
Malfunction
Summary report: N
MAQUET CARDIOPULMONARY AG
MDR report key: 3829407
·
Received March 18, 2014
Report
- Report Number
- 8010762-2014-00116
- Event Type
- Malfunction
- Date Received
- March 18, 2014
- Date of Event
- February 18, 2014
- Report Date
- February 18, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTZ
- PMA / PMN Number
- K943803
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
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 MAQUET SERVICE TECHNICIAN INVESTIGATED THE DEVICE AND REPLACED THE INTERCONNECT PCB, RIGHT SIDE MOTOR AND POWER BUTTON LENS. A COMPLETE PREVENTATIVE MAINTENANCE WITH FULL CALIBRATION AND FUNCTIONAL TESTING TO FACTORY SPECIFICATIONS WAS SUCCESSFULLY PERFORMED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERMITTENT "REV REL" (REVERSE RELAY) ERROR MESSAGE APPEARED AT POWER UP AND THE RIGHT SIDE MOTOR RAN ROUGH AT LOW RPM. NO PATIENT INVOLVEMENT. INTERNAL REFERENCE: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 158573 | MAQUET CARDIOPULMONARY AG | HL 20 CONSOLE BASE | DTZ | MAQUET CARDIOPULMONARY AG | 701035075 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |