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: 07feb2019.No phone number provided.A follow-up report will be submitted once the investigation has been completed.

Event Description

Customer contacted technical support (ts) stating that unit was in patient use and had error codes of hi pressure reg and over pressure condition.The customer reported there was no patient involvement.

Manufacturer Narrative

Date of report: 20jun2019.Date received by manufacturer: 19jun2019.Philips remote support engineer advised customer of multiple parts to repair the device, they also informed the customer that one possible part was no longer available the remote support engineer also offered bench repair as an option to troubleshoot the device if the customer approved.Philips remote support engineer contacted the customer as a follow up call and the customer indicated that they had scrapped the device 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: 8316747
• MDR Text Key: 135708867
• Report Number: 2031642-2019-00774
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1