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

Device Problems Intermittent Continuity (1121); Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019.On (b)(4) 2019.Serial number unknown.Reporter phone number unknown.A follow-up report will be submitted once the investigation is completed.

Event Description

The customer contacted technical support (ts) stating that unit turns itself on and off, usually around ten (10) minutes at a time.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 received by mfr: 30aug2019.Report date: 03sep2019.There is no patient information available.

Manufacturer Narrative

Date rec¿d by mfr : 22aug2019, date of report : 29aug2019.The device was sent to bench repair.The bench repair technician identified blower spend exceeded error.The bench repair technician identified that the controller printed circuit board needed to be replaced.They advised the customer that the controller printed circuit board has been discontinued.The customer requested the unit back to be scrapped.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: 8264416
• MDR Text Key: 133764758
• Report Number: 2031642-2019-00443
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2019

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 01/03/2019; 01/03/2019
• Supplement Dates FDA Received: 08/29/2019; 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT CIRCUIT, MASK, HUMIDIFIER: UNKNOWN