FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 4093217
·
Received August 21, 2014
Report
- Report Number
- 8010042-2014-00369
- Event Type
- Malfunction
- Date Received
- August 21, 2014
- Date of Event
- May 15, 2014
- Report Date
- July 23, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
BIOMED ON SITE HAS STARTED THE INVESTIGATION. TROUBLESHOOTING SHOWED THAT THE OXYGEN GAS MODULE HAD A DEFECTIVE NOZZLE UNIT. 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 PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504566 | SERVO-I | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |