MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AUX500T15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information from an end user alleging while using a continuous positive airway pressure (cpap) device his partial denture plate became dislodged and subsequently required surgery to remove the partial denture plate from his esophagus.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be submitted.
Additional Manufacturer Narrative
The manufacturer received the cpap and associated humidifier for investigation.The memory on this device has been cleared by the customer for use on a different patient after the reported event.The investigation found no evidence of a failure of the received devices.The prescribed pressure range set on the auto cpap was a minimum pressure of 5 cm h2o and a maximum pressure of 15 cm h2o.The patient encore report download obtained by the customer for this patient was received and on the first night of usage on (b)(6) 2019-(b)(6) 2019 was used by the patient for approximately 8.85 hours with the max pressure obtained at 15 cm h2o during usage with no issues.The second night of usage on the night of (b)(6) 2019, the date of the event, was used for approximately 1 hour with a maximum pressure obtained of only 10 cm h2o, not ramping up to max pressure as alleged by the patient.The device delivered pressures to the patient within the preset range of 5-15 cm h2o on both nights of usage.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) kg ((b)(6) lbs.).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, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use.Contact your home care provider." based on the information available, the manufacturer concluded that the device did not malfunction or fail to perform to document specifications.The event that was reported is consistent with an inherent risk associated with the use of partial denture plate, and there is no evidence to suggest that use of cpap therapy caused or contributed to the event or its severity.

• Brand Name: DREAMSTATION AUTO CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 8591988
• Report Number: 2518422-2019-01016
• Device Sequence Number: 1981776
• Product Code: BZD
• UDI-Device Identifier: 00606959026018
• UDI-Public: 00606959026018
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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: AUX500T15
• Device Catalogue Number: AUX500T15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEATED HUMIDIFIER H163282466DA6; HEATED HUMIDIFIER H163282466DA6
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention