MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION CPAP PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE: BZD,,

Model Number	GBX400S15
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/28/2018
Type of Reportable Event	Death
Event or Problem Description
The manufacturer became aware of a patient death.A family member is alleging that the continuous positive airware pressure (cpap) device may have caused or contributed to the patient's death.The date of death is unknown and there has been no other information provided to date.It is unknown if the patient was wearing the cpap device at the time of death.The investigation is on-going.Upon completion of the investigation, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer received the devices for investigation.There was no evidence of a failure of the received devices that would have caused or contributed to the reported event.There were no operational issues found.The devices performed as intended and passed all testing.The philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over (b)(6).It is for use in the home or hospital/institutional environment.The user is cautioned "contact your health care professional if symptoms of sleep apnea recur.If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, or if the enclosure is broken, disconnect the power cord from the therapy device and discontinue use.Contact your home care provider." this device is not intended for life support.Based on the available information, the manufacturer concludes that no further action is necessary at this time.

• Brand Name: DREAMSTATION CPAP PRO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE: BZD,,
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 8120172
• Report Number: 2518422-2018-02839
• Device Sequence Number: 16193588
• Product Code: BZD
• UDI-Device Identifier: 00606959023482
• UDI-Public: 00606959023482
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: GBX400S15
• Device Catalogue Number: GBX400S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/08/2019
• 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