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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 25june2019.The manufacturer's service support confirmed a proximal pressure sensor autozero error code.It was not duplicated.The gas delivery system (gds) was replaced as preventive action.No other abnormalities were confirmed.Unit was checked overall and passed the functional and run in tests.

Event Description

It was reported that the ventilators had an error code 110a recorded in the log data during preventative maintenance.No patient involvement.

Manufacturer Narrative

G4: 06oct2019; b4: 11oct2019.The returned gas delivery system was tested, and no failures were identified.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: 8731748
• MDR Text Key: 149379658
• Report Number: 2031642-2019-04064
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 06/16/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1