FDA Adverse Event
Malfunction
Summary report: N
FLOW-I C20
MDR report key: 3901770
·
Received May 5, 2014
Report
- Report Number
- 8010042-2014-00182
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Report Date
- April 4, 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
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL MEDWATCH REPORT WILL BE PROVIDED WHEN THE INVESTIGATION IS FINISHED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE ON A PATIENT, THE STAFF NOTICED THAT ONE OF THE TWO ABSORBER BYPASS VALVES HAD BECOME LOOSE AND THIS GENERATED A LEAKAGE BETWEEN THE PATIENT CASSETTE AND THE CO2 ABSORBER. AUDIBLE AND VISIBLE ALARMS WERE GENERATED TO NOTIFY THE USER. THERE WAS NO PATIENT HARM REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268016 | FLOW-I C20 | BSZ | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |