FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 4960569
·
Received August 3, 2015
Report
- Report Number
- 2031642-2015-01461
- Event Type
- Malfunction
- Date Received
- August 3, 2015
- Report Date
- July 7, 2015
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- MNT
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PMA 510(K): K082660. BRAND NAME - V60 VENTILATOR. COMMON DEVICE NAME - VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT. MODEL - V60 . CONTACT OFFICE: (B)(4).
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).
Description of Event or Problem · 1
THE MANUFACTURER'S FIELD SERVICE ENGINEER REPORTED A CHECK VALVE ON THE OXYGEN MANIFOLD LEAKED WHEN THE MANIFOLD WAS CONNECTED TO WALL OXYGEN SOURCE PRESSURE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 1
THE MANUFACTURER'S FIELD SERVICE ENGINEER REPORTED A CHECK VALVE ON THE OXYGEN MANIFOLD LEAKED WHEN THE MANIFOLD WAS CONNECTED TO WALL OXYGEN SOURCE PRESSURE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 505903 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |