FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 3770417
·
Received February 18, 2014
Report
- Report Number
- 8010042-2014-00035
- Event Type
- Malfunction
- Date Received
- February 18, 2014
- Date of Event
- January 27, 2014
- Report Date
- January 29, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SERVICE ENGINEER HAS BEEN ON SITE AND COMPLETED THE INVESTIGATION. TROUBLESHOOTING SHOWED THAT THE REPORTED COMPRESSOR FAILURE WAS CAUSED BY A DETECTIVE AIR GAS MODULE IN THE VENTILATOR THAT WAS CONNECTED TO THE COMPRESSOR. THE AIR GAS MODULE WAS REPLACED AND THE REPORTED VENTILATOR WAS PUT BACK IN SERVICE. 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 DURING PT TREATMENT A COMPRESSOR CONNECTED TO A VENTILATOR GENERATED LOW PRESSURE ALARM. BOTH COMPRESSOR AND VENTILATOR WERE REPLACED AND THERE WAS NO PT HARM. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103410 | SERVO-I | CBK | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |