FDA Adverse Event
Malfunction
Summary report: N
FLOW-I C30
MDR report key: 3941744
·
Received March 5, 2014
Report
- Report Number
- 8010042-2014-00072
- Event Type
- Malfunction
- Date Received
- March 5, 2014
- Date of Event
- January 30, 2014
- Report Date
- February 5, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- BSZ
- PMA / PMN Number
- K112114
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN FINALIZED. REFERENCE EXEMPTION #: (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SYSTEM CHECK OUT, THE ANESTHESIA MACHINE FAILED THE INSPIRATORY/EXPIRATORY VALVE TEST. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 131650 | FLOW-I C30 | BSZ | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |