VYAIRE MEDICAL
Report
- Report Number
- 8030673-2024-01001
- Event Type
- Malfunction
- Date Received
- March 5, 2024
- Date of Event
- January 10, 2024
- Report Date
- March 5, 2024
- Manufacturer
- VYAIRE MEDICAL
- Product Code
- BTT
- UDI-DI
- 10190752115200
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE IS AN INTERFERENCE IN THERAPY AND VENTILATION. BASED ON THE INVESTIGATION AND PER PICTURES SENT BY THE CUSTOMER WE CAN CONFIRM THE REPORTED DEFECT. CUSTOMER REPORTED THAT THE DIFFUSER "POROUS STONE" PART NUMBER 65-4197 IS BLOCKED. GIVEN THAT THE REPORTED COMPONENT IS PURCHASED FROM A SUPPLIER, THE SUPPLIER PROVIDES US WITH A CERTIFICATE CERTIFYING THAT COMPONENT 65-4197 MEETS THE SPECIFIED POROSITY ACCORDING TO OUR PROCEDURES. IT'S POSSIBLE THAT THE BATCH SENT BY OUR SUPPLIER OF COMPONENT 65-4197 DID NOT HAVE THE REQUIRED POROSITY FOR THE PRODUCTION OF (B)(4), LEADING TO THE REPORTED DEFECT. "SINCE THE REPORTED DEFECT WAS CONFIRMED THE FOLLOWING ACTIONS WERE TAKEN: A QUALITY NOTIFICATION HAS BEEN SENT TO OUR SUPPLIER OF THE COMPONENT P/N 65-4197. AN INSPECTION WILL BE CONDUCTED ON THE NEXT 5 BATCHES OF PART NUMBER 65-4197 ARRIVING AT OUR FACILITY."
THERE IS AN INTERFERENCE IN THERAPY AND VENTILATION.
CANNISTER HAS PROBLEMS WITH THE POROUS STONE BECOMING BLOCKED AND THE PATIENT NOT GETTING FLOW. PATIENT NOT GETTING FLOW.
CANNISTER HAS PROBLEMS WITH THE POROUS STONE BECOMING BLOCKED AND THE PATIENT NOT GETTING FLOW. PATIENT NOT GETTING FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103151 | VYAIRE MEDICAL | CANNISTER HAS PROBLEMS WITH THE POROUS STONE BECOMING BLOCKED AND THE PATIENT NO | BTT | VYAIRE MEDICAL | 002003 | 0004169337 | 10190752115200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |