FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 4093264
·
Received September 16, 2014
Report
- Report Number
- 2031642-2014-01042
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Report Date
- August 18, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- MNT
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VENTILATOR BATTERY CHARGE INDICATOR IS FLASHING. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. AS THE DEVICE WAS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT (PSE) FOR ASSISTANCE. THE BIOMEDICAL ENGINEER REPORTED THE VENTILATOR DID NOT SHUT DOWN BUT THE BATTERY WAS CHARGING FOR A LONG TIME. PSE ADVISED EVALUATION AND TESTING OF THE BATTERY. THE BIOMEDICAL ENGINEER REPORTED THE POWER MANAGEMENT PCB BOARD WAS REPLACED AND THE REPORTED PROBLEM RESOLVED. POWER FAILURE DUE TO LOSS OF BATTERY POWER MAY RESULT IN SHUTDOWN OF DEVICE DURING NORMAL VENTILATION OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571123 | V60 VENTILATOR | VENTILATOR, CONTINUOUS | MNT | RESPIRONICS CALIFORNIA, INC. | V60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |