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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date received by manufacturer: 06 november 2019.Date of this report: 07 november 2019.The service engineer (se) inspected the device.The se replaced the flow sensor to address the reported issue.The unit passed all testing.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.

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 10/16/2019.

Event Description

It was reported that the ventilators flow readings out of specification.There was no patient involvement.

Manufacturer Narrative

G4: 14feb2020 b4: (b)(6)2020.A gas delivery system (gds) was returned for analysis.A visual inspection of the returned component was performed and the unit was received without data acquisition (da) board and oxygen (o2) valve.Visual inspection revealed no anomalies.An investigation was performed and the product analysis technician reported that the root cause was due to air flow sensor caused by a component drifting out of specification.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: 9197317
• MDR Text Key: 184989907
• Report Number: 2031642-2019-10113
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 10/03/2019; 10/03/2019
• Supplement Dates FDA Received: 11/07/2019; 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1