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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 17june2019.A follow-up report will be submitted once the investigation has been complete.

Event Description

Customer reported bipap focus does not stay on.It is unknown if the device was in use at the time of the event or if there was a patient harm reported.

Manufacturer Narrative

Date received by manufacturer: 20 july 2019.Date of this report: 13 november 2019.The field service engineer (fse) replaced user interface board and internal battery.Ran battery charging test, reloaded system software, ran system calibration and ran performance verification.All testing passed.The determination could not be made that the device failed to meet specifications.It is unknown if the device was being used for treatment when the reported event occurred, and there is not relationship of the device to the reported problem.No parts were returned for failure investigation, therefore the root cause at the component level could not be determined.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 8706002
• MDR Text Key: 148278610
• Report Number: 2031642-2019-03893
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1