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

Model Number	DS6TFLG
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Vomiting (2144); Dizziness (2194); Cancer (3262); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503); Skin Inflammation/ Irritation (4545); Eye Irritation (4803)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
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 eye irritation, skin irritation, respiratory tract irritation, dizziness and/or headache, kidney disease/toxicity, lung disease and cancer.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: SYSTEM ONE HT HUMID ASSY
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18407510
• Report Number: 2518422-2023-38135
• Device Sequence Number: 2673687
• Product Code: BZD
• UDI-Device Identifier: 00606959032132
• UDI-Public: 00606959032132
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

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: DS6TFLG
• Device Catalogue Number: DS6TFLG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2013
• 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: Life Threatening
• Patient Sex: Unknown