MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION HUMID, CORE PACK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	EUXHCP
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Nasal Obstruction (2466); Electric Shock (2554); Dry Mouth (4485)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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 patient experienced electric shocks and headaches.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Device not returned to manufacturer.
Additional Manufacturer Narrative
The manufacturer previously reported information of a device returned to a third-party service center 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 patient also alleges that the humidity is too high and is blocking her nose, waking up with dry mouth and feeling dizziness.The patient took prescribed medications.In this report, section b1 - adverse event/product problem has been updated.Section b3 - event date has been updated.Section b7 - other relevant history has been updated.Section h1 - type of reported complaint has been updated.Section h6 - adverse event problem health effect - clinical and impact code has been updated.

• Brand Name: DREAMSTATION HUMID, CORE PACK
• 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 15208 ; 4125423300
• MDR Report Key: 19236808
• Report Number: 2518422-2024-24794
• Device Sequence Number: 18151276
• Product Code: BZD
• UDI-Device Identifier: 00606959023246
• UDI-Public: 00606959023246
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: EUXHCP
• Device Catalogue Number: EUXHCP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2021
• 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
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown