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

Model Number	DEX400S13
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Respiratory Tract Infection (2420); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
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.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported an issue related related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient harm or injury.The manufacturer received an issue related to a cpap, bipap, and mechanical ventilator devices sound abatement foam become degraded and alleged chronic sinusitis.There was no report of serious patient harm or injury.Despite of multiple attempts the device has not yet returned to the manufacturer for evaluation.The manufacturer received new and relevant information on 01/04/2022 patient refuses to return the device for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow-up report.In addition, appropriate health effect - clinical code, type of investigation, investigation findings, investigation conclusions has been added on h6 section.

• Brand Name: DREAMSTATION CPAP PRO, GER
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• Manufacturer (Section G): RESPIRONICS INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburg, PA 15206 ; 2673970028
• MDR Report Key: 12598554
• Report Number: 2518422-2021-04957
• Device Sequence Number: 3420184
• Product Code: BZD
• UDI-Device Identifier: 00606959024083
• UDI-Public: 00606959024083
• 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): 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): 01/06/2023

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: DEX400S13
• Device Catalogue Number: DEX400S13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2019
• 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
• Patient Sex: Unknown