FDA Adverse Event
Death
Summary report: N
LTV 1200 VENTILATOR
MDR report key: 9072715
·
Received September 16, 2019
Report
- Report Number
- 2031702-2019-03322
- Event Type
- Death
- Date Received
- September 16, 2019
- Date of Event
- August 19, 2019
- Report Date
- August 19, 2019
- Manufacturer
- VYAIRE MEDICAL
- Product Code
- CBK
- UDI-DI
- 00845873002726
- PMA / PMN Number
- K060647
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
RESULTS OF INVESTIGATION: VYAIRE MEDICAL EVALUATED THE SUSPECT DEVICE. THE VENTILATOR PASSED 169 HOURS OF EXTENDED TESTS AT THE CUSTOMER'S SETTINGS. THE VENTILATOR PASSED FINAL TEST WHICH INCLUDES MANY ALARM AND VENTILATION FUNCTIONS.
Additional Manufacturer Narrative · 1
VYAIRE COMPLAINT NUMBER: (B)(4). ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED TO VYAIRE THAT A PATIENT EXPIRED WHILE CONNECTED TO THE LAP TOP VENTILATOR 1150. AT THIS TIME, THERE IS NO ALLEGATION AGAINST THE VENTILATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 864272 | LTV 1200 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VYAIRE MEDICAL | LTV 1150 | 00845873002726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |