MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Increase in Pressure (1491)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 10/30/2019.

Event Description

It was reported that the unit intermittently declared an over pressure alarm.There was no patient involvement.

Manufacturer Narrative

Date received by mfr: (b)(6) 2019.Date of report: (b)(6) 2019.The manufacturer's field service engineer (fse) performed troubleshooting and confirmed the reported issue.The unit intermittently alarmed "over pressure".The unit also failed flow and pressure readings with all readings being low and the display case assembly was cracked.The fse replaced the main and display case assembly, the blower and flow valve assembly.The unit passed performance verification and safety testing.The device was not being used for treatment when the reported event occurred, and there is a relationship between the device and 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.

Manufacturer Narrative

G4: 27mar2020.B4: 30mar2020.The harmony valve assembly and blower assembly were returned for failure analysis.A visual inspection revealed no signs of damage or contamination.During testing, 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: BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 9257568
• MDR Text Key: 176997797
• Report Number: 2031642-2019-10336
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• PMA/PMN Number: K053168
• 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: 10/22/2019

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: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 10/22/2019; 10/22/2019
• Supplement Dates FDA Received: 12/10/2019; 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1