MAUDE Adverse Event Report: RESPIRONICS BIPAP AVAPS C SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1160P
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hypoventilation (1916); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a bipap avaps c series alarmed and had a ventilator inoperative condition.The patient was admitted to the hospital.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported a bipap avaps c series alarmed and had a ventilator inoperative condition.The patient was admitted to the hospital.The device was returned to the manufacturer's quality assurance laboratory for further investigation.The device passed all testing and was found to operate to design specifications.The ventilator inoperative condition could not be duplicated.A review of the device's error log indicates the ventilator inoperative conditions did occur on the day of the reported event.The manufacturer found two ultra-fine filters installed in the device, when the manufacturer recommends one ultra-fine filter to be installed.Dark colored contaminates were found on the filters and in the device's airpath and blower assembly.The device's patient event report was downloaded and reviewed.The report confirmed the alarms were disabled.

• Brand Name: BIPAP AVAPS C SERIES
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 7148632
• Report Number: 2518422-2017-02967
• Device Sequence Number: 1133310
• Product Code: MNS
• UDI-Device Identifier: 00606959039216
• UDI-Public: 00606959039216
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K092818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1160P
• Device Catalogue Number: 1160P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 27 YR