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

Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2018.Date of report: 26july2019.The manufacturer¿s field service engineer (fse) replaced the blower assembly and flow valve assembly to address the reported problem.The unit successfully passed the required performance verification test.The focus blower assembly and flow valve assembly were returned for evaluation.Visual inspection of the returned parts revealed no evidence of damage or contamination.The failure investigation test was performed on the focus blower and flow valve assembly with a test ventilator in an attempt to duplicate the reported problem.During debugging the flow valve assembly found a break between the black wires inside the insulation wire refers to photo attached.The black wire was solder together and the heat shrink tube was installed over the wire.The test ventilator did power up from ac and deliver breaths, the ac led indicator did activate, and the test ventilator did not display error code over pressure condition.It was also noted that the system test did pass and the ventilator did operate for two hours without failures and no failures.The root cause for the reported issue is due to the focus flow valve broken black wire, which created the error code.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.

Event Description

The customer reported error code over pressure condition.It is unknown if the unit was in patient use at the time of the reported issue.No patient or user harm was reported.

• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 8833092
• MDR Text Key: 152541779
• Report Number: 2031642-2019-05123
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2018

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: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2011
• 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