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

Model Number	NDX500S15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Epistaxis (4458)
Date of Event	01/01/2017
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 a patient to develop epistaxis, headaches, nausea and tooth loss.There is no report of the medical intervention that the patient has received at this time.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
Additional information was received on nov 11, 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 received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to develop nosebleeds, headaches, nausea and tooth loss.There is no report of the medical intervention that the patient has received at this time.The sections b1, b2, h1, h6 have been corrected in this report as follows: section b1 was corrected to product problem (adverse event and product problem was checked in the previous mdr).Section b2 was changed to blank (previously it was other serious).Section h1 was changed from serious injury to malfunction.Section h6 health effect - impact code was corrected.

• Brand Name: DREAMSTATION AUTO CPAP, ND
• 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: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12542342
• Report Number: 2518422-2021-04410
• Device Sequence Number: 5337988
• Product Code: BZD
• UDI-Device Identifier: 00606959027206
• UDI-Public: 00606959027206
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: NDX500S15
• Device Catalogue Number: NDX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• 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: Unknown