FDA Adverse Event
Summary report: N
OXYGEN TUBING
MDR report key: 4080780
·
Received September 6, 2014
Report
- Report Number
- MW5038099
- Date Received
- September 6, 2014
- Report Date
- September 6, 2014
- Manufacturer
- RCI HUDSON
- Product Code
- CAT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THESE SERIOUSLY DEFECTIVE OXYGEN TUBING PRODUCTS ALMOST CHOKED ME TO DEATH BY CUTTING OFF MY OXYGEN SUPPLY WHILE USING MY OXYGEN CONCENTRATOR MACHINE BY KNOTTING UP AND KINKING UP NOT ALLOWING ME TO RECEIVE OXYGEN PROPERLY, IN ORDER TO BREATH PROPERLY. THIS POORLY MADE POTENTIALLY DEADLY PRODUCT SHOULD BE RECALLED IMMEDIATELY. THEY ARE HUDSON RCI REF 1827, SOFTECH ADULT NASAL CANNULA, HUDSON RCI OXYGEN TUBING WATER TRAP AND SALTER LABS, REF 2021-21 SUPPLY LINE TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 546980 | OXYGEN TUBING | SOFT ADULT NASAL CANNULA | CAT | RCI HUDSON | RCI 1827 | 99434 | |
| 546981 | SUPPLY LINE TUBING | NASAL CANNULA | CAT | SALTER LABS | |||
| 546982 | OXYGEN TUBING WATER TRAP | WATER TRAP | BYH | RCI HUDSON |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Life Threatening| O |