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

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 08april2019.No phone number provided.Manufacturer's field service engineer (fse) evaluated the unit and confirmed the reported issue.The fse replaced the unit's user interface (ui) pcba and battery to resolve the reported issue.Fse performed system calibration and performance verification and all tests passed.Unit ready for service.

Event Description

Customer contacted technical support (ts) stating that unit had error code message of power on self test (post) board over temp.Issue was found on post.No patient involvement was reported by the customer.Event date not specified; estimate used.

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 25jun19.This complaint is a duplicate of (b)(4).This event was reported on mfr.Report #: 2031642-2019-02160.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: 8494021
• MDR Text Key: 141320045
• Report Number: 2031642-2019-02138
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1