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

Model Number	AUX400T15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dyspnea (1816); Headache (1880); Tinnitus (2103); Wheezing (4463); Eye Pain (4467); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/01/2019
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 shortness of breath.The patient did receive medical intervention in the form of a prescription for acid reflux pills.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.Corrected data: d4 unique identifier (udi) number: previously reported as (b)(4) ; updated to (b)(4).D8 was this device serviced by a third party?: previously reported as no ; updated to unknown.E4 initial reporter also sent report to fda?: previously reported as no ; updated to unknown.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.A correction to b5 was made and should be: additional information was received and section b5 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 an issue related to a cpap device's sound abatement foam.The patient has alleged to experience sore eyes shortness of breath, wheeze, stomach pain, palpitation in the ears, sore nose and headaches.The reported events were reviewed by the manufacturer's clinical expert.Based on the information available, the manufacturer concludes no further action is necessary.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.Section b1, b2 has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect-impact code, type of investigation, investigation findings and investigation conclusions have been updated.

• 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: 12388954
• Report Number: 2518422-2021-03533
• Device Sequence Number: 11965852
• 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
• Report Date (Section B): 08/25/2023

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: AUX400T15
• Device Catalogue Number: AUX400T15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/04/2023
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/15/2021; 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Female