MAUDE Adverse Event Report: RESPIRONICS BIPAP A30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1111143
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/14/2017
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a bipap a30 had a ventilator inoperative condition while in patient use.The patient expired.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 a30 allegedly had a ventilator inoperative condition while in patient use.The patient expired.The reporting facility stated that the patient was not using the device when the patient expired.The device was returned to the manufacturer's service center for evaluation.The customer's complaint of the ventilator inoperative condition was not confirmed.The manufacturer concludes the device did not cause or contribute to the patient's death.

• Brand Name: BIPAP A30
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 7067753
• Report Number: 2518422-2017-02697
• Device Sequence Number: 118027
• Product Code: MNS
• UDI-Device Identifier: 00606959039308
• UDI-Public: 00606959039308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113053
• 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
• Report Date (Section B): 11/14/2017

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: 1111143
• Device Catalogue Number: 1111143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/25/2018
• 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