FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 3249980
·
Received July 26, 2013
Report
- Report Number
- 2031642-2013-00363
- Event Type
- Malfunction
- Date Received
- July 26, 2013
- Report Date
- July 12, 2013
- 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 IS OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS SERVICE. OUT OF WARRANTY; NO REQUEST FOR MNF SERV.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE DEVICE SHUT DOWN DURING OPERATION AND WOULD NOT TURN BACK ON. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. THE CUSTOMER REPORTED TO MANUFACTURERS PRODUCT SUPPORT (PSE) THAT FURTHER EVALUATION FOUND THE UNIT WOULD NOT OPERATE ON AC POWER WITH BATTERY DISCONNECTED. AS THE DEVICE WAS OUT OF WARRANTY, THE CUSTOMER REPORTED THE POWER MANAGEMENT PCB BOARD WILL BE REPLACED TO ADDRESS THE REPORTED PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351463 | V60 VENTILATOR | VENTILATOR, CONTINUOUS | MNT | RESPIRONICS CALIFORNIA, INC. | V60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |