MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP W/HUM/HT/CELL, AU; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AUX500T15C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Cough (4457)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have cough.The patient was prescribed medication in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging patient to have cough and headaches related to a cpap device's sound abatement foam.The medical intervention that the patient received in response to the event is currently unknown.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date a follow-up report will be filed.The reported event that the customer had coughing and headaches, requiring medication while using a dreamstation and its reported severity 2 was reviewed by the pms clinical expert.This event is assessed as possibly related to the product problem with the device and/or use error.Correction: corrected information provided in h.6.(event headaches missed to capture in initial mdr) section h6 updated in this report.
Additional Manufacturer Narrative
Additional information was received on nov 04, 2024, and section h11 should be reported as: the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging patient to have cough and headaches related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of serious patient harm or injury.Sections b1, b2, h1 and h6 have been corrected in this report as follows: section b1 was corrected for only the product problem (both adverse events and product problem was checked in the previous mdr.) section b2 was corrected to blank.(previously, it was other serious or important medical events.) section h1 was changed from serious injury to malfunction.Section h6 health effects - impact code was corrected.

• Brand Name: DREAMSTATION AUTO CPAP W/HUM/HT/CELL, AU
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer Contact: rosko melissa ; 6501, living place; pittsburgh, PA 15206 ; 7249003460
• MDR Report Key: 12447997
• Report Number: 2518422-2021-03729
• Device Sequence Number: 17038686
• Product Code: BZD
• UDI-Device Identifier: 00606959034808
• UDI-Public: 00606959034808
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2024

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: AUX500T15C
• Device Catalogue Number: AUX500T15C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 01/02/2023; Not provided
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 07/18/2023; 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male