FDA Adverse Event
Malfunction
Summary report: N
VYAIRE MEDICAL
MDR report key: 18823128
·
Received March 1, 2024
Report
- Report Number
- 8030673-2024-01000
- Event Type
- Malfunction
- Date Received
- March 1, 2024
- Date of Event
- February 1, 2024
- Report Date
- March 1, 2024
- Manufacturer
- VYAIRE MEDICAL
- Product Code
- CAI
- UDI-DI
- 10190752122741
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE HOLES IN THE HOSE COULD INTERFERE WITH VENTILATORY SUPPORT.
Additional Manufacturer Narrative · 0
THE HOLES IN THE HOSE COULD INTERFERE WITH VENTILATORY SUPPORT. "BASED ON THE INVESTIGATION AND SINCE NO PICTURES OR PHYSICAL SAMPLE OF FG AGNX2XXX WITH LOT NUMBER 0004258034 WAS PROVIDED WE CANNOT CONFIRM THE REPORTED DEFECT SINCE WE REQUITE THE PHYSICAL SAMPLE TO PERFORM A BETTER INVESTIGATION. THE ROOT CAUSE WAS NOT ESTABLISHED NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN.
Description of Event or Problem · 0
PRODUCT INTEGRITY.
Description of Event or Problem · 0
PRODUCT INTEGRITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237368 | VYAIRE MEDICAL | ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG | CAI | VYAIRE MEDICAL | AGNX2XXX | 0004258034 | 10190752122741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |