MAUDE Adverse Event Report: RESPIRONICS BIPAP A40; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number	GB1061X
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/16/2017
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a bipap c series was not working properly.The hospital offered a replacement device to the caregiver but the offer was declined as the caregiver stated the device was now working properly.The patient expired the next morning.The device has yet to be evaluated by the manufacturer's service center.A follow up report will be filed when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported a bipap c series was allegedly not working properly.The hospital offered a replacement device at the time but the offer was declined as the caregiver stated the device was now working.The patient was reported to have expired the next morning on (b)(6) 2017.The device was returned to the manufacturer for evaluation.The device was visually inspected and was found to have heavily contaminated inlet filters which likely contributed to the ventilator inoperative condition.Product labeling indicates, "operating the device with a dirty filter may keep the system from working properly and may damage the device." the device was tested and was found to not audibly alarm.Further investigation found the speaker lead (j11) to be disconnected from the pca (printed circuit assembly).The manufacturer connected the speaker lead and verified the device does audibly alarm.The device's device history record was reviewed and confirmed the device passed all associated alarm testing at the time of manufacture.The manufacturer cannot determine how or when the cable became disconnected after it was released for sale.The device's event/error log was downloaded and reviewed.The manufacturer confirmed ventilator inoperative error codes were logged on (b)(6) 2017 indicating that the device had stopped working.The log did not contain any other error codes.The device did not generate any ventilator inoperative events during the evaluation.The encore patient report was downloaded and reviewed by the manufacturer.The report indicated that the last date and time of therapy was on (b)(6) 2017 at 3:39pm.The device was not in use on the day of the reported event on (b)(6) 2017.The manufacturer did not duplicate the reported event, and the device was not in patient use at the time of the event.The device was tested and was found to operate to design specifications with the exception of the audible alarm due to the disconnected cable.The device is not intended for life support.The device does not provide ventilation with guaranteed tidal volume delivery.Evaluation conclusion: the device is being retained by the manufacturer.
Additional Manufacturer Narrative
Correction: the manufacturer incorrectly reported the date received by the manufacturer as 04/09/2018.The correct date received by the manufacturer is 05/07/2018.

• Brand Name: BIPAP A40
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 7071227
• Report Number: 2518422-2017-02695
• Device Sequence Number: 10978937
• Product Code: MNT
• UDI-Device Identifier: 00606959043633
• UDI-Public: 00606959043633
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2017

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: GB1061X
• Device Catalogue Number: GB1061X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/23/2017
• Supplement Date Received by Manufacturer: 04/09/2018; 04/09/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 05/09/2018; 05/10/2018
• 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: Death