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

Device Problem Decrease in Pressure (1490)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 18march2019.The field service engineer (fse) evaluated the device at the customer site.The blower and flow valve assemblies were replaced to address the issue.The ventilator passed all testing and operated within the manufacturing specifications.

Event Description

The customer reported that the ventilator low pressure alarm was reoccurring more often than normal.The ventilator was not in use on a patient at the time of the event occurred.Event date not specified; estimate used.

Manufacturer Narrative

Date of report: 26jun2019.Date received by manufacturer: 27may2019.The blower assembly and flow valve assembly were received for evaluation.Visual inspection of both parts revealed no evidence of damage or contamination.The parts were installed into a test ventilator in order to try to duplicate the reported issue.The blower and flow valve assembly were tested and no 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.

• 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: 8428617
• MDR Text Key: 139090304
• Report Number: 2031642-2019-01552
• 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
• Report Date: 02/12/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1