MAUDE Adverse Event Report: RESPIRONICS, INC. SYSTEM ONE 60 SERIES HEATED HUMID; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DS6H
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503)
Date of Event	10/09/2023
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 nose irritation, respiratory tract irritation, dizziness and/or headache, kidney disease/toxicity.There was report of serious or permanent harm or injury.Device has not been returned to the manufacture for evaluation.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
Due to a discrepancy with the customer reported serial number of the humidifier compared to the base device units registered to the customer, the model and serial number of the base device is unknown.Additional information is not available at this time.

• Brand Name: SYSTEM ONE 60 SERIES HEATED HUMID
• 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: 20751683
• Report Number: 2518422-2024-071525
• Device Sequence Number: 8088763
• Product Code: BZD
• UDI-Device Identifier: 00606959006607
• UDI-Public: (01)00606959006607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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: DS6H
• Device Catalogue Number: DS6H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2014
• 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-1973-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown