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

Device Problem Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 27march2019.No phone number provided.A follow-up report will be submitted once the investigation has been complete.

Event Description

Customer contacted technical support (ts) stating that unit had error message of blower failure the customer reported there was no patient involvement.Event date not specified, estimate used.

Manufacturer Narrative

Date rec'd by mfr: 19nov2019.Date of report: 21nov2019.Failure analysis on the returned bipap focus blower shows that this bipap focus blower assembly was tested and no functional 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.

Manufacturer Narrative

G4: 20may2019, b4: 11oct2019.The service engineer replaced the blower assembly to address the reported issue.The unit passed all testing required.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.

Event Description

Customer contacted technical support (ts) stating that unit had error message of blower failure.The customer reported there was no patient involvement.Event date not specified, estimate used.

• 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: 8466520
• MDR Text Key: 140598807
• Report Number: 2031642-2019-01913
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2019

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: 11/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/11/2019; 03/11/2019
• Supplement Dates FDA Received: 10/11/2019; 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1