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

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 03/02/2020.

Event Description

It was reported that the unit declared an over pressure condition.The device was in use at the time of the event; however, there was no patient harm.The manufacturer's remote service technician performed troubleshooting with the customer.The customer ran the unit but was unable to duplicate the error.The technician recommended that the customer perform a complete check of the unit with passing results before placing the unit back in service.

Manufacturer Narrative

G4: 10apr2020; b4: 13apr2020.H11: correction to b1: h1.The customer reported that the unit was in use on a patient during the event with no harm noted.Due to limited information provided, provision of medical intervention to prevent/preclude harm is unclear and therefore has not been ruled out.Assessment of complaint with this assumption has been considered via clinical risk review and shall be reported as serious injury.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: 26mar2020 b4: (b)(6)2020.The customer reported that the issue has been resolved.No parts were required.The unit was checked, passed all testing and was returned to 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: 9777487
• MDR Text Key: 188969949
• Report Number: 2031642-2020-00695
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/06/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/06/2020; 02/06/2020
• Supplement Dates FDA Received: 03/30/2020; 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.