MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	DEX1130S13
Medical Device Problem Codes	Degraded (1153); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the device with an allegation that the device foam needed replaced in relation to the device recall.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 regarding the foam recall.The manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted to correct the description of the event or problem previously reported.The dreamstation bipap s/t was returned to a third-party service center for service.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at a third-party service center, the device showed no signs of foam degradation.Furthermore, there is no evidence to suggest that the device malfunctioned in a way that could lead to death or serious injury if the issue were to recur.Therefore, this complaint is not reportable to any regulatory agencies.
Event or Problem Description
This report is being submitted to correct the description of the event or problem previously reported.The dreamstation bipap s/t was returned to a third-party service center for service.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at a third-party service center, the device showed no signs of foam degradation.Furthermore, there is no evidence to suggest that the device malfunctioned in a way that could lead to death or serious injury if the issue were to recur.Therefore, this complaint is not reportable to any regulatory agencies.

• Brand Name: DREAMSTATION
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 20181208
• Report Number: 2518422-2024-100455
• Device Sequence Number: 8364281
• Product Code: MNS
• UDI-Device Identifier: 00606959426313
• UDI-Public: (01)00606959426313
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial,Followup

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: Other
• Device Model Number: DEX1130S13
• Device Catalogue Number: DEX1130S13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2020
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown