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

Device Problems Thermal Decomposition of Device (1071); Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 25apr2019.The customer was performing preventative maintenance (pm) and replaced the case, battery, and flow valve.Customer found the reported issues during that time.Manufacturer's field service engineer (fse) evaluated the unit and verified the reported issues.Fse found error code for high pressure and replaced the unit touch user interface printed circuit board assembly and battery to resolve the reported issues.Fse reloaded the system software.Fse also performed system calibration and performance verification testing (pvt.All testing passed.Unit ready for service.

Event Description

The customer contacted technical support stating that unit had thermal damage and error code message of soft anomaly.The customer reported there was no patient involvement.Event date not specified: estimate used.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: greg ayers ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 8552497
• MDR Text Key: 143213637
• Report Number: 2031642-2019-02453
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/01/2019

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1