FDA Adverse Event
Death
Summary report: N
V60 VENTILATOR
MDR report key: 4964610
·
Received August 4, 2015
Report
- Report Number
- 2031642-2015-01481
- Event Type
- Death
- Date Received
- August 4, 2015
- Date of Event
- July 14, 2014
- Report Date
- July 9, 2015
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- MNT
- PMA / PMN Number
- K082660
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
SEVERAL ATTEMPTS TO OBTAIN INFORMATION HAVE BEEN MADE BUT CUSTOMER HAS NOT PROVIDED ENOUGH INFORMATION TO DETERMINE A ROOT CAUSE OF THE REPORTED EVENT. THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS, AND THE DEVICE IS USED FOR TREATMENT. THE V60 VENTILATOR WAS IN USE, AND THERE IS A RELATIONSHIP OF THE DEVICE TO AN ADVERSE EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VENTILATOR DID NOT ALARMED WHEN THE MASK GET DISCONNECTED FROM THE PATIENT. THE PATIENT DESATURATED AND EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 506298 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |