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

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 01/22/2020.

Event Description

The customer reported that the ventilator shows system error code indicating insufficient voltage for audible alarm.No patient or user harm was reported.

Manufacturer Narrative

G4: 04mar2020 b4: (b)(6)2020.The customer was informed the part needed to repair is no longer available and the customer decided to decommission the unit.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: 9618511
• MDR Text Key: 180787586
• Report Number: 2031642-2020-00279
• 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: 01/09/2020

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1