FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 3930062
·
Received July 11, 2014
Report
- Report Number
- 2031642-2014-00661
- Event Type
- Malfunction
- Date Received
- July 11, 2014
- Report Date
- June 16, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- MNT
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
OUT OF WARRANTY REPAIR, NO REQUEST FOR SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING AND DISPLAYING A VENT INOP MESSAGE. THE BIO-MED REPORTED THE DEVICE WAS IN USE ON PATIENT , BUT NO THERE WAS NO PATIENT HARM. THE BIO-MED REPORTED THE VENT INOP WAS A DATA ACQUISITION PCBA ADC REFERENCE FAILURE. VENT INOP IS A HIGH PRIORITY CONDITION THAT PRECLUDES SAFE OPERATION OF THE VENTILATOR. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE PATIENT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT. THE BIO-MED REPORTED THE DATA ACQUISITION PCB BOARD WAS REPLACED TO ADDRESS THE REPORTED PROBLEM. THE UNIT IS NOW BACK IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406740 | V60 VENTILATOR | VENTILATOR, CONTINUOUS | MNT | RESPIRONICS CALIFORNIA, INC. | V60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |