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

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 12april2019.Manufacturer's field service engineer (fse) evaluated the unit and confirmed the reported issue.Fse replaced the unit's user interface (ui) board and battery to resolve the reported issue.Unit was tested and all testing passed.Unit ready for service.

Event Description

Customer contacted technical support (ts) stating that unit had power on issue and error code message of power on self test (post) board over temp.The customer reported there was no patient involvement.Event date not specified, estimate used.

Manufacturer Narrative

Date rec'd by mfr: 31jul2019.The returned focus blower assembly and focus flow valve assembly was installed in a failure investigation test ventilator.They were able to reproduce the reported complaint.They found a wire break on the flow valve.The failure investigation technician connected the wire and reinstalled the part in the test vent with no following failures.The focus flow valve broken white wire created the error over pressure condition.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: 8509235
• MDR Text Key: 141924532
• Report Number: 2031642-2019-02198
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/16/2019

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: 05/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1