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

Model Number	DEX500S13
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Epistaxis (4458); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
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.Corrected data: b3 date of event: previously reported as 26-jul-2021 ; updated to 23-jul-2021.
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 reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged nosebleeds and severe respiratory problems mucus in the throat black particles.The device was returned to the third party service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected and dust contamination was found.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed.There were no error found.The third party service center concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Section h6, in the previous report; they missed to capture clinical code for nosebleeds and severe respiratory problems mucus in the throat black particles, that was captured in this report.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12274520
• Report Number: 2518422-2021-02656
• Device Sequence Number: 11462186
• Product Code: BZD
• UDI-Device Identifier: 00606959024090
• UDI-Public: 00606959024090
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2024

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: DEX500S13
• Device Catalogue Number: DEX500S13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 04/04/2022
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/10/2021; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2017
• 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
• Patient Sex: Unknown