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	Asthma (1726); Headache (1880); Inflammation (1932); Dizziness (2194); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503)
Date of Event	10/12/2023
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 an issue related to a cpap device's humidifier sound abatement foam.The patient alleged asthma.In addition, the patient also reported nose irritation, inflammatory response, dizziness, headache, kidney disease and lung disease.Medical intervention was not specified by the patient.Due to potential litigation surrounding this case, no follow up can be performed at this time.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
H3 other text : device has not been returned to the manufacturer.

• 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: 19347110
• Report Number: 2518422-2024-29150
• Device Sequence Number: 20456107
• Product Code: BZD
• UDI-Device Identifier: 00606959006607
• UDI-Public: 00606959006607
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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
• 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: 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: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2012
• 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