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

Model Number V60

Device Problems Vibration (1674); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 12/17/2019.

Event Description

It was reported that the ventilator had a noise (vibrational sound) was coming from the left side (battery attached part) of the unit while a post-use test run was performed.There was no patient involvement.

Manufacturer Narrative

Date received by manufacturer: 16dec2019.Report date: 20dec2019.The manufacturer¿s international service technician found a slight vibrational noise in blower was confirmed.The vibration dampening ring was repositioned then the issue was fixed.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.The determination could not be made that the device failed to meet specifications.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 were returned to failure investigation; therefore, the root cause of the reported issue could not be determined.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: 9484205
• MDR Text Key: 181194068
• Report Number: 2031642-2019-10904
• 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
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1