MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Increase in Pressure (1491)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 01/03/2020.

Event Description

The customer reported high o2 (oxygen) pressure, and no o2 available.There was no patient involvement.

Manufacturer Narrative

G4: 15jan2020.B4: (b)(6).The manufacturer¿s field service engineer (fse) could not replicate the problem.Replaced all parts ordered.Performed full testing.All tests passed.No fault found.(est) extended self test passed.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.No parts returned to failure investigation; therefore, the root cause of the reported issue could not be determined.If parts are returned, the complaint will be reopened and an investigation will be performed.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

G4: 25feb2020 b4: (b)(6)2020.The oxygen (o2) solenoid and daq board were returned to the manufacturer for failure investigation (fi).After testing, it was determined that the customer complaint was not verified.There was no fault found.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 9546856
• MDR Text Key: 181426071
• Report Number: 2031642-2020-00022
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1