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

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 03april2019.The manufacturer's field service engineer (fse) evaluated the unit and confirmed the reported issue.The fse also found the casing was damaged.The fse replaced the unit's blower and flow valve assembly to resolve the reported issue.The fse also replaced the unit's main housing casing to resolve the broken casing.The unit was tested and passed.The unit was ready for service.

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 received by manufacturer: 02jul2019.Date of report: 02jul2019.A visual inspection of the blower assembly revealed no evidence of damage or contamination.Further evaluation determined that a focus flow valve broken wire caused the reported 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: 8479154
• MDR Text Key: 140904174
• Report Number: 2031642-2019-02010
• 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: 03/13/2019

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: 04/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT CIRCUIT, MASK, HUMIDIFIER: UNKNOWN