FDA Adverse Event
Malfunction
Summary report: N
SUPER SOFT
MDR report key: 2929885
·
Received January 9, 2013
Report
- Report Number
- 2929885
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Report Date
- January 9, 2013
- Manufacturer
- WESTMED, INC.
- Product Code
- CAT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
NEW INFANT NASAL CANNULA WITH SOFT TUBING CAUSED LOUD AND HIGH PITCH NOISE WHEN ATTACHED TO OXYGEN HUMIDIFIER. THE BOTTLE WOULD BURST AND WATER WOULD SHOOT OUT ONCE THE HUMIDIFIER WAS REMOVED. CHANGED THE NS HUMIDIFIER THREE TIMES, AND CHANGED THE OXYGEN CONNECTOR TWICE AND IT STILL MADE LOUD NOISE. SWITCHED NEW TUBING TO THE OLD PEDIATRIC NASAL CANNULA O2 TUBING AND IT RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11510 | SUPER SOFT | CANNULA, NASAL, OXYGEN | CAT | WESTMED, INC. | * | 01172012T42 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 MO |