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) 2020.Date of this report: 27-feb-2020.

Event Description

It was reported that the unit declared an "insufficient voltage for audible alarm" error.There was no patient involvement.The manufacturer's field service engineer (fse) performed troubleshooting and confirmed the reported issue.The customer was advised that part replacement needed is not available and to remove the unit from service.The part needed to repair the unit is no longer available.The unit has been decommissioned.

Manufacturer Narrative

G4: 04mar2020.B4: 10mar2020.H11 mfr.Report #:2031642-2020-00676 is a duplicate of an event previously reported under mfr.Report #:2031642-2020-00279.Any additional information will be submitted under the initially reported mfr.Report #:2031642-2020-00279.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: 9766488
• MDR Text Key: 190549772
• Report Number: 2031642-2020-00676
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1