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

Model Number	AUX400T15C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Respiratory Tract Infection (2420); Cough (4457)
Date of Event	08/05/2021
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 became degraded and the patient developed congestion, cough, and plastic breaking into two pieces.The patient did receive medical intervention in the form of prescribed antibiotics.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 an allegation of an issue related to sound abatement foam.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 received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged plastic breaking from mask, cough, blocked nose, congestion, heavy headaches and painful ears since this event and patient had a ct scan and was taking pain killers and antibiotics for some days.The reported events cough, blocked nose, congestion, heavy headaches and painful ears due to the device and its reported severity was reviewed by the manufacture's clinical expert.This events are not meet the definition of a reportable serious injury in this case.Based on the available information, 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 a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.  section(s) 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 has been updated in this report.

• Brand Name: DREAMSTATION CPAP PRO W/HUM/HT/CELL, 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: 12310919
• Report Number: 2518422-2021-03038
• Device Sequence Number: 4137230
• Product Code: BZD
• UDI-Device Identifier: 00606959034792
• UDI-Public: 00606959034792
• 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): 04/14/2023

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: AUX400T15C
• Device Catalogue Number: AUX400T15C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/03/2022
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/13/2021; 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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 Sex: Female