FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 5029063
·
Received August 25, 2015
Report
- Report Number
- 2031642-2015-01662
- Event Type
- Malfunction
- Date Received
- August 25, 2015
- Report Date
- July 28, 2015
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- MNT
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
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 THE VENTILATOR ALARMED AND DISPLAYED A VENT INOP DATA ACQUISITION PCBA ADC REFERENCE FAILURE AND MACHINE AND PROXIMAL SENSOR FAILURES . THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND DISPLAYED A VENT INOP DATA ACQUISITION PCBA ADC REFERENCE FAILURE AND MACHINE AND PROXIMAL SENSOR FAILURES . THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 562582 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |