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

Model Number V60

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Event date: (b)(6) 2019.Date of report: 17sep2019.

Event Description

The customer reported a ventilator that will not remain in standby mode.No patient involvement / harm.

Manufacturer Narrative

G4: 23mar2020.B4: 24mar2020.The manufacturer¿s technical services (ts) confirmed the reported issue.Customer reports that after replacing the power overlay board the unit is now reporting machine and proximal pressure sensors failed.Customer also indicated a odor that may be a defective component but can't locate any obvious damage on any of the boards.After numerous attempts to obtain information on the repair of this device (see communication notes), this complaint is being closed.If further information is obtained, this complaint will be reopened.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: 9075285
• MDR Text Key: 164723376
• Report Number: 2031642-2019-09500
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• 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
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1