FDA Adverse Event
Malfunction
Summary report: N
AIRFLOW
MDR report key: 6105382
·
Received November 16, 2016
Report
- Report Number
- 2246980-2016-00069
- Event Type
- Malfunction
- Date Received
- November 16, 2016
- Report Date
- October 18, 2016
- Manufacturer
- VENTLAB LLC.
- Product Code
- BTM
- PMA / PMN Number
- K012842
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EXTENSIVE AND THOROUGH INVESTIGATION WAS PERFORMED BY THE ENGINEERING TEAM THAT CONCLUDED THE ROOT CAUSE FOR THIS PROBLEM IS THE FACT THAT THE PATIENT PORT AND THE MASK ARE MADE OUT OF SIMILAR BASE MATERIALS RESULTING IN AN UNDESIRABLY HIGH COEFFICIENT OF FRICTION BETWEEN THE TWO PARTS. STEPS HAVE BEEN TAKEN TO IMPLEMENT A MATERIAL COMBINATION WITH A LOWER COEFFICIENT OF FRICTION THAT SIGNIFICANTLY REDUCES THE EFFORT REQUIRED TO REMOVE THE MASK FROM THE PATIENT VALVE. NOT RETURNED.
Description of Event or Problem · 1
THE CUSTOMER ALLEGES "THE MASK IS SO TIGHTLY CONNECTED TO THE MANUAL RESUS BAG THAT IT CANNOT BE REMOVED." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758622 | AIRFLOW | RESUS BAG | BTM | VENTLAB LLC. | AF1140MC | 305191 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |