MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR SYSTEM ONE 60 SERIES; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	562P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	08/12/2024
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 damage to the lung tissue, shortness o breath and fear of serious injury.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 previous report incorrectly stated the reporter country field (under the adverse event information tab).This report has corrected it.

• Brand Name: REMSTAR SYSTEM ONE 60 SERIES
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20040284
• Report Number: 2518422-2024-100137
• Device Sequence Number: 20862487
• Product Code: BZD
• UDI-Device Identifier: 00606959037892
• UDI-Public: (01)00606959037892
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K113068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

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: 562P
• Device Catalogue Number: 562P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2015
• 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