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

Model Number	DS6HFLG
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Liver Damage/Dysfunction (1954); Dizziness (2194); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545); Eye Irritation (4803)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified about a voluntary field safety notice/recall related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received reports alleging that the patient experienced eye irritation, skin irritation, respiratory tract irritation, dizziness and/or headache, and liver disease/toxicity.No specific medical intervention was mentioned.The manufacturer was made aware of this information through the customer¿s legal representative.Due to potential legal issues surrounding this case, no further investigation or follow-up can be conducted.If any additional information is received, a follow-up report will be submitted.
Additional Manufacturer Narrative
The model number (ds6hflg8) and serial number (b)(6) noted in this report correspond to a humidifier.The base device is unknown but has been reported as a remstar auto a-flex w/hum,sysone60srs,dom, as this is the most likely corresponding product.

• Brand Name: SYSTEM ONE HTD HUMID ASSY ,DOM
• 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: 19579175
• Report Number: 2518422-2024-38251
• Device Sequence Number: 3980354
• Product Code: BZD
• UDI-Device Identifier: 00606959032149
• UDI-Public: 00606959032149
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• 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): 06/20/2024

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: DS6HFLG
• Device Catalogue Number: DS6HFLG
• 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: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2016
• 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