FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 4092815
·
Received August 20, 2014
Report
- Report Number
- 8010042-2014-00364
- Event Type
- Malfunction
- Date Received
- August 20, 2014
- Date of Event
- August 8, 2014
- Report Date
- August 14, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER HAS BEEN ON SITE AND STARTED THE INVESTIGATION. THE AIR GAS MODULE WAS FOUND DEFECTIVE AND IT WAS REPLACED. THE DEFECTIVE 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 THE VENTILATOR FAILED THE INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500779 | SERVO-I | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |