FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 5004872
·
Received August 14, 2015
Report
- Report Number
- 2031642-2015-01596
- Event Type
- Malfunction
- Date Received
- August 14, 2015
- Report Date
- July 23, 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
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
CONTACT INFORMATION: (B)(4).
Additional Manufacturer Narrative · 1
EVENT DATE: (B)(6) 2015. CONCLUSION / ROOT CAUSE: THIS IS THE OLD STYLE DATA ACQUISITION TO MOTOR CONTROLLER CABLE. NO FURTHER FI IS REQUIRED. PLEASE REFERENCE CAPA (B)(4). THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED AND DISPLAYED CODES THAT INDICATED AN SPI BUS FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 539832 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |