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

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019.On (b)(4) 2019.The manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem.The fse replaced the blower and flow valve assembly to resolve the reported issue.The fse ran a system calibration and performance verification.All testing passed.

Event Description

The customer contacted philips technical support (ts) stating that the unit had an error code message of over pressure condition.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.The event date was not specified; estimate used.

Manufacturer Narrative

Date of report : 25jun2019, date rec¿d by mfr : 24jun2019.A the focus blower and flow valve assembly was returned for analysis.An investigation was performed and the focus flow valve broken white wire created error code message of over pressure condition.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: 8262034
• MDR Text Key: 133715764
• Report Number: 2031642-2019-00423
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

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: 02/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 01/02/2019
• Supplement Dates FDA Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT CIRCUIT, MASK, HUMIDIFIER: UNKNOWN