FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 6040575
·
Received October 19, 2016
Report
- Report Number
- 2031642-2016-02787
- Event Type
- Malfunction
- Date Received
- October 19, 2016
- Report Date
- September 22, 2016
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- MNT
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THE UNIT SERIAL NUMBER IS (B)(4). THE CUSTOMER REPORTED THAT DURING THE EXHALATION PORT TEST, THE TEST FAILED AND THE SCREEN DISPLAY ¿PRESSURE TOO LOW ¿. THE CUSTOMER REPORTED THAT THE CONNECTION OF PEV VALVE AND TUBING WAS CORRECTED, THE TEST WAS REPEATED AND THE TEST PASSED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR HAS LOW PRESSURE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692305 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |