MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION CELLULAR MODEM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	100605C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Headache (1880); Inflammation (1932); Nausea (1970); Dizziness (2194); Unspecified Heart Problem (4454); 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 yet returned to the 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 reporter alleged of having eye irritation, nose irritation, skin irritation, respiratory tract irritation, dizziness and/or headache, nausea/vomiting, kidney disease/toxicity, lung disease, reduced cardiopulmonary reserve, heart attack, asthma (new or worsening) and inflammatory response.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.

• Brand Name: DREAMSTATION CELLULAR MODEM
• 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: 19298909
• Report Number: 2518422-2024-27549
• Device Sequence Number: 6015738
• Product Code: BZD
• UDI-Device Identifier: 00606959023871
• UDI-Public: 00606959023871
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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

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: 100605C
• Device Catalogue Number: 100605C
• 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: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2016
• 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