FDA Adverse Event
Death
Summary report: N
LTV 1150 VENTILATOR
MDR report key: 11951937
·
Received June 7, 2021
Report
- Report Number
- 2021710-2021-13994
- Event Type
- Death
- Date Received
- June 7, 2021
- Date of Event
- April 6, 2021
- Report Date
- May 12, 2021
- Manufacturer
- VYAIRE MEDICAL
- Product Code
- CBK
- UDI-DI
- 00845873002726
- PMA / PMN Number
- K060647
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
VYAIRE MEDICAL WAS NOT ABLE TO DUPLICATE THE REPORTED ISSUE. EVALUATION REVEALED UUT (UNIT UNDER TEST) WAS TESTED AND FOUND TO FUNCTION NORMALLY. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. LINKED TO (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT PATIENT PASSED AWAY WHILE ON THE LAP TOP VENTILATOR 1150. THE CUSTOMER CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE SUSPECT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 843429 | LTV 1150 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VYAIRE MEDICAL | LTV 1150 | 00845873002726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |