FDA Adverse Event
Malfunction
Summary report: N
FLOW-I C30
MDR report key: 3831962
·
Received March 7, 2014
Report
- Report Number
- 8010042-2014-00076
- Event Type
- Malfunction
- Date Received
- March 7, 2014
- Date of Event
- February 28, 2014
- Report Date
- February 28, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- BSZ
- PMA / PMN Number
- K112114
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN FINALIZED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE ANESTHESIA SYSTEM GENERATED ALARMS FOR LOW FIO2 CONCENTRATION. THERE WAS NO HARM TO THE PT REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139064 | FLOW-I C30 | BSZ | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |