FDA Adverse Event
Malfunction
Summary report: N
COMPRESSOR MINI
MDR report key: 4090097
·
Received August 18, 2014
Report
- Report Number
- 8010042-2014-00344
- Event Type
- Malfunction
- Date Received
- August 18, 2014
- Date of Event
- March 26, 2014
- Report Date
- March 26, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- BTI
- PMA / PMN Number
- K023354
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPRESSOR'S MOTOR WAS REPLACED BY OUR FIELD SERVICE ENGINEER. THE REPLACED PART HAS BEEN REQUESTED FOR INVESTIGATION, BUT NOT YET RECEIVED. A SUPPLEMENTAL MDR REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A COMPRESSOR MINI DISPLAYED LOW PRESSURE DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 496249 | COMPRESSOR MINI | BTI | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |