MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	DSX900T11C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Cancer (3262); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545); Eye Irritation (4803)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.
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, nose irritation, skin irritation, dizziness and/or headache and cancer.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.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
The manufacturer was previously 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, nose irritation, skin irritation, dizziness and/or headache and cancer.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Now, the manufacturer received device information on 12/17/2024.The device was returned to a third-party service center for evaluation.During evaluation of the device at third-party service center, it is observed that there was no visible foam degradation found.The device was scrapped.Updated - product brand name, fda product code, common device name, model number, catalog item identifier, serial number, product udi, 510k, manufacture date, evaluation method code grid, evaluation results code grid, component code grid and conclusion code grid updated.The exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021 and z-1974-2021.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 20447042
• Report Number: 2518422-2024-62321
• Device Sequence Number: 8524333
• Product Code: MNS
• UDI-Device Identifier: 00606959045385
• UDI-Public: (01)00606959045385
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K090539
• 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,Followup
• Report Date (Section B): 12/31/2024

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: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2017
• 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