FDA Adverse Event
Death
Summary report: N
LTV 1200 VENTILATOR
MDR report key: 10708582
·
Received October 20, 2020
Report
- Report Number
- 2031702-2020-03715
- Event Type
- Death
- Date Received
- October 20, 2020
- Date of Event
- September 21, 2020
- Report Date
- September 21, 2020
- Manufacturer
- VYAIRE MEDICAL
- Product Code
- CBK
- UDI-DI
- 00845873000364
- PMA / PMN Number
- K060647
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
VYAIRE COMPLAINT NUMBER: (B)(4). ANY ADDITIONAL INFORMATION PROVIDED BY THE REPORTER WILL BE INCLUDED IN A FOLLOW UP SUBMISSION. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED TO VYAIRE MEDICAL BY THE ASSISTANT DISTRICT ATTORNEY OF (B)(6) DISTRICT ATTORNEY'S OFFICE THAT A CHILD PASSED AWAY WHILE CONNECTED TO THE LAP TOP VENTILATOR 1200. AT THIS TIME, THERE ARE NO ALLEGATIONS AGAINST THE VENTILATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1171951 | LTV 1200 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VYAIRE MEDICAL | LTV 1200 | 00845873000364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |