FDA Adverse Event
Malfunction
Summary report: N
BELLAVISTA 1000 VENTILATOR
MDR report key: 19472170
·
Received June 5, 2024
Report
- Report Number
- 3013421741-2024-00157
- Event Type
- Malfunction
- Date Received
- June 5, 2024
- Date of Event
- April 17, 2024
- Report Date
- June 5, 2024
- Manufacturer
- VYAIRE MEDICAL, INC
- Product Code
- CBK
- UDI-DI
- 07640149381115
- PMA / PMN Number
- K163127
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
VYAIRE MEDICAL INVESTIGATION FILE # (B)(4). THE VYAIRE MEDICAL'S TECHNICAL SUPPORT TEAM ANALYZED THE LOGFILES. ADDITIONAL TROUBLESHOOTING IS CURRENTLY STILL IN PROGRESS. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 0
VYAIRE MEDICAL'S TECHNICAL SERVICE TEAM WAS ABLE TO CONFIRM THE CUSTOMER'S REPORTED ISSUE. THE DEFECTIVE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER, THE LOG FILE ANALYSIS TOOL WAS UTILIZED TO DETERMINE THE ROOT CAUSE: DEFECTIVE MOOG BLOWER UNIT.
Description of Event or Problem · 0
IT WAS REPORTED TO VYAIRE MEDICAL A TF 401 ALARM APPEARED. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1089513 | BELLAVISTA 1000 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VYAIRE MEDICAL, INC | BELLAVISTA 1000 VENTILATOR | 07640149381115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |