MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION CPAP PRO W/HUMID/HT, AUS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AUX400T15
Medical Device Problem Codes	Degraded (1153); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was visualization of black flecks in the humidifier chamber.The patient alleges to have skin irritation.There was no report of patient harm or injury.The device was returned to the manufacturer's quality product investigation laboratory for further investigation.The device was visually inspected externally and found no evidence of thermal or physical damage or foam material.The humidifier had evidence of corrosion and small cracks in the pan.There was no evidence of the pan leaking.The humidifier flip lid tab was not working properly.A reiew of the device''s event log found 2 errors logged when received.An e4 and e200 were logged and is not related to the reported events.The device was tested and no errors were logged during investigation.The device was powered up and provided therapy.An visual internal inspection was completed by the manufacturer.The manufacturer found no failure of the sound abatement foam or any odors in the blower motor, blower box or in the air path of the device.The manufacturer concludes there was no evidence of sound abatement foam degradation and that the device operated properly.Updated section h6; please see section h6 for updated coding.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.Section h6 medical device problem code was coded incorrectly on the previous report.

• Brand Name: DREAMSTATION CPAP PRO W/HUMID/HT, AUS
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12065838
• Report Number: 2518422-2021-01839
• Device Sequence Number: 11615846
• Product Code: BZD
• UDI-Device Identifier: 00606959025981
• UDI-Public: 00606959025981
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: AUX400T15
• Device Catalogue Number: AUX400T15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 07/15/2021; 07/15/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 09/09/2021; 06/22/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEATED HUMIDIFIER SN (B)(6).
• Patient Sex: Unknown