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

Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.

Event Description

The customer reported an over pressure condition error.There was no patient involvement.

Manufacturer Narrative

G4: 10jul2020 b4: (b)(6)2020 the manufacturer¿s technical services (ts) confirmed the reported issue.The customer was advised that the controller and blower are not available due to end of life (eol) and was provided with a discontinuation letter.The customer was provided with the eol letter and informed that there are no parts available for this unit.Multiple attempts were made to confirm this information with the customer.If further information is obtained, a supplemental report will be submitted.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: 27aug2020.B4: 28aug2020.The customer stated the unit has been removed from service.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: 9960359
• MDR Text Key: 188263996
• Report Number: 2031642-2020-01325
• 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,Followup
• Report Date: 03/24/2020

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 03/24/2020; 03/24/2020
• Supplement Dates FDA Received: 07/11/2020; 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1