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

Model Number	DEXH
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Stroke/CVA (1770); Dehydration (1807); Electric Shock (2554); Syncope/Fainting (4411)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a patient experienced electrical shock from heated tubing while using a dreamstation auto cpap device.The patient alleges he switched back to the normal tubing days later and passed out and was in the hospital for 8 hours.The doctors couldn't tell him what had taken place; however, the patient claim he had a stroke.The patient also alleges dehydration during the therapy, the humidifier setting was on level 5, the mask test showed 100% and ahi value was less than 5.The device was returned to the manufacturer's product investigation laboratory (pil) for investigation.The device was applied power and verified airflow.While verifying airflow pil observed that the pressure reading was low likely due to the humidifier lid seal and dry box seal missing from the humidifier.Using a known good, heated tube pil verified that the tube functioned properly and did not observe any type of shock.During the investigation, pil observed the humidifier lid seal, and the dry box seal was not returned with the humidifier.A dust like contamination on the top enclosure, bottom enclosure, bottom enclosure of the humidifier, bottom panel, back panel, blower motor, and the blower motor seal.An unknown contamination on the front panel, bottom enclosure, dry box, bottom panel and the rear panel.Hair-like fibers on the bottom enclosure, bottom enclosure of the humidifier, dry box and the bottom panel.Pil observed evidence of liquid ingress to the bottom enclosure, heater plate, and the humidifier flip lid with an unknown white dust like contamination consistent with mineral deposits on the blower motor, blower motor seal, and the blower box.The manufacturer was unable to directly address the symptoms and was not able to confirm the complaint of electrical shock from heated tubing.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Event or Problem Description
The manufacturer received information alleging a patient experienced electrical shock from heated tubing while using a dreamstation auto cpap device.The patient alleges he switched back to the normal tubing days later and passed out and was in the hospital for 8 hours.The doctors couldn't tell him what had taken place; however, the patient claim he had a stroke.The patient also alleges dehydration during the therapy, the humidifier setting was on level 5, the mask test showed 100% and ahi value was less than 5.The device was returned to the manufacturer's product investigation laboratory (pil) for investigation.The device was applied power and verified airflow.While verifying airflow pil observed that the pressure reading was low likely due to the humidifier lid seal and dry box seal missing from the humidifier.Using a known good, heated tube pil verified that the tube functioned properly and did not observe any type of shock.During the investigation, pil observed the humidifier lid seal, and the dry box seal was not returned with the humidifier.A dust like contamination on the top enclosure, bottom enclosure, bottom enclosure of the humidifier, bottom panel, back panel, blower motor, and the blower motor seal.An unknown contamination on the front panel, bottom enclosure, dry box, bottom panel and the rear panel.Hair-like fibers on the bottom enclosure, bottom enclosure of the humidifier, dry box and the bottom panel.Pil observed evidence of liquid ingress to the bottom enclosure, heater plate, and the humidifier flip lid with an unknown white dust like contamination consistent with mineral deposits on the blower motor, blower motor seal, and the blower box.The manufacturer was unable to directly address the symptoms and was not able to confirm the complaint of electrical shock from heated tubing.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
This report was submitted incorrectly and is a duplicate.Additionally, this report pertains to the humidifier device, while the base device was accurately filed under mdr 2518422-2025-048881.

• Brand Name: DREAMSTATION AUTO CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 23653085
• Report Number: 2518422-2025-112117
• Device Sequence Number: 11987830
• Product Code: BZD
• UDI-Device Identifier: 00606959024113
• UDI-Public: (01)00606959024113
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: DEXH
• Device Catalogue Number: DEXH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2020
• 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
• 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