FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 5035024
·
Received August 27, 2015
Report
- Report Number
- 2031642-2015-01663
- Event Type
- Malfunction
- Date Received
- August 27, 2015
- Report Date
- July 27, 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
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 MANUFACTURER'S SERVICE TECHNICIAN REPORTED THAT DURING SERVICING THE DEVICE ALARMED AND SHUT DOWN DUE TO A PRESSURE REGULATION HIGH FAILURE WHEN THE UNIT WAS TURNED ON. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569829 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |