FDA Adverse Event
Death
Summary report: N
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
MDR report key: 11733095
·
Received April 27, 2021
Report
- Report Number
- 2021710-2021-13692
- Event Type
- Death
- Date Received
- April 27, 2021
- Date of Event
- April 1, 2021
- Report Date
- June 24, 2021
- Manufacturer
- VYAIRE MEDICAL
- Product Code
- CBK
- UDI-DI
- 00845873000029
- PMA / PMN Number
- K070594
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
VYAIRE COMPLAINT #: (B)(4). RESULTS OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECTED DEVICE AND PERFORMED A FAILURE INVESTIGATION. THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. DURING TESTING, THE MODULE BLOWER WAS FOUND TO FAIL THE LEAK TEST. THE BLOWER MODULE WAS REPLACED, AND THE DEVICE PASSED ALL TESTING. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO VYAIRE MEDICAL THAT A PATIENT EXPIRED WHILE CONNECTED TO THE REVEL VENTILATOR. THE CUSTOMER REPORTED THAT THE DEVICE DID NOT DELIVER BREATHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631115 | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VYAIRE MEDICAL | REVEL | 00845873000029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |