FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 4213342
·
Received October 24, 2014
Report
- Report Number
- 2031642-2014-01291
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Report Date
- September 30, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- MNT
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
RESEATED THE DATA ACQUISITION TO MOTOR CONTROLLER CABLE.
Description of Event or Problem · 1
THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR ALARMED AND DISPLAYED A VENT INOP DATA ACQUISITION PCB ADC FAILURE. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON A PT; THEREFORE, THERE WAS NO PT INVOLVEMENT OR HARM. A VENT INOP CONDITION DURING NORMAL VENTILATION OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. THE USER MUST PROVIDED ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED. THE MFR'S SERVICE ENGINEER REPORTED A CONNECTION FAILURE OF THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB CABLE. THE SERVICE ENGINEER REPORTED THE CABLE WAS RECONNECTED TO CORRECT THE REPORTED PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 680083 | V60 VENTILATOR | VENTILATOR, CONTINUOUS | MNT | RESPIRONICS CALIFORNIA, INC. | V60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |