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

Model Number	DEX400S13
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Dyspnea (1816)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
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 asthma.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
The manufacturer previously received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop asthma.There is no report of the medical intervention that the patient has received at this time.In previous report, section b5 was incorrect, correct b5 should be - 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 cpap device's sound abatement foam.The patient has alleged difficulty breathing.There was no report of serious or permanent patient harm or injury.The device was returned to an authorized service center for evaluation.The device was visually inspected.The service center found no contamination.The device passed all final test.In this report, section b1, b2, b6, d9, g3, h1, h3, h6 has been updated or corrected.
Additional Manufacturer Narrative
Additional information was received on nov 08 2024, and section h10 should be reported as: the manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop asthma.There is no report of the medical intervention that the patient has received at this time.Section b1 was corrected for both adverse event and product problem.( product problem was checked in the previous mdr.) section b2 was corrected to other serious or important medical events.(previously, it was blank.) section h1 was changed from malfunction.To serious injury.Section h6 was corrected and updated.

• Brand Name: DREAMSTATION CPAP PRO, GER
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPORINOC INC; 101 murry ridge lane; murrysville, pa PA 15668
• Manufacturer (Section G): RESPORINICS, INC; 1001 murry ridge lane; murrysville,pa PA 15668
• Manufacturer Contact: rosko melissa ; 6501 living place; pittisburgh,pa, PA 15206 ; 7243512041
• MDR Report Key: 12432616
• Report Number: 2518422-2021-03698
• Device Sequence Number: 3255198
• 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,Followup
• Report Date (Section B): 02/05/2025

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: DEX400S13
• Device Catalogue Number: DEX400S13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 08/31/2022; 11/08/2024
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 06/12/2023; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2016
• 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