FDA Adverse Event
Malfunction
Summary report: N
WESTMED LLC
MDR report key: 17312277
·
Received July 12, 2023
Report
- Report Number
- 2028807-2023-00020
- Event Type
- Malfunction
- Date Received
- July 12, 2023
- Date of Event
- June 12, 2023
- Report Date
- July 12, 2023
- Manufacturer
- WESTMED LLC
- Product Code
- CAF
- UDI-DI
- 00709078000409
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE NEBULIZER'S FAILURE TO RELEASE AEROSOL AND THE TUBING POPPING OFF WOULD DELAY TREATMENT TO THE PATIENT. COMPLAINT IS NOT CONFIRMED. TESTING OF A DIFFERENT LOT FROM INVENTORY WAS FOUND AND UNITS FAILED SO NCMR-03535 WAS INITIATED. REVIEWED THE DHR AND NO QUALITY ISSUES WERE IDENTIFIED. PERFORMED A RISK ANALYSIS WITH RMA-20013F AND DETERMINED A SEVERITY RATING OF 6/10. SENT A RESOLUTION TO THE CUSTOMER.
Additional Manufacturer Narrative · 0
THE NEBULIZER'S FAILURE TO RELEASE AEROSOL AND THE TUBING POPPING OFF WOULD DELAY TREATMENT TO THE PATIENT.
Description of Event or Problem · 0
TUBING BECOMES DISCONNECTED FROM THE VENTILATOR.
Description of Event or Problem · 0
TUBING BECOMES DISCONNECTED FROM THE VENTILATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 794932 | WESTMED LLC | VIXONE NEBULIZER | CAF | WESTMED LLC | 0210 | 412159 | 00709078000409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |