FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 3870813
·
Received June 12, 2014
Report
- Report Number
- 2031642-2014-00491
- Event Type
- Malfunction
- Date Received
- June 12, 2014
- Report Date
- May 16, 2014
- 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
SUPPLEMENTAL REPORT
Additional Manufacturer Narrative · 1
COMPLETION OF DEVICE EVALUATION AND SERVICE PENDING.
Description of Event or Problem · 1
THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR WAS ALARMING DUE TO AN OCCLUSION AND THERE WAS NO AIR FLOW. THE VENTILATOR WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. COMPLETION OF DEVICE EVALUATION AND SERVICE IS PENDING.
Description of Event or Problem · 1
THE MANUFACTURERS SERVICE ENGINEER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. UNIT TESTING PASSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347317 | V60 VENTILATOR | VENTILATOR, CONTINUOUS | MNT | RESPIRONICS CALIFORNIA, INC. | V60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |