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

Model Number V60

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 10/25/2019.The remote technician performed troubleshooting with the customer.The customer reported that when the flow was set to 0, they received a reading of -21.The call was routed to the field.The manufacturer's field service engineer (fse) performed troubleshooting and confirmed the reported issue.The fse also noted that the unit declared a low leak co2 rebreathing alarm which was duplicated during troubleshooting.The fse replaced the flow sensor assembly and both issues were resolved.The unit passed performance verification testing.No parts were returned to failure investigation; therefore, the root cause of the reported issue could not be determined.

Event Description

It was reported that the customer was unable to perform leak testing on the unit.There was no patient involvement.

Manufacturer Narrative

Date received by manufacturer: 29dec2019.Date of this report: (b)(6) 2019.The gas delivery system (gds) was returned for failure analysis.A visual inspection showed no signs of damage or contamination.During analysis, it was determined that the air flow sensor failure was caused by the u1 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: 9240321
• MDR Text Key: 170699429
• Report Number: 2031642-2019-10259
• 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
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1