FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 4921841
·
Received July 17, 2015
Report
- Report Number
- 2031642-2015-01332
- Event Type
- Malfunction
- Date Received
- July 17, 2015
- Report Date
- June 24, 2015
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- MNT
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
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 INTERNATIONAL CUSTOMER REPORTED THAT THE VENTILATOR ALARMED WITH A DATA ACQUISITION PCB ADC FAILURE OCCURRENCE. THERE WASN'T ANY PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 465704 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |