MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PLUS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	260P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cancer (3262); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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 that the patient alleging throat and sinus problems.There was no report of medical intervention.The manufacturer was made aware of this complaint through a representative of the customer.The device has not been returned to the manufacturer.At this time, no further investigation can be performed at this time.If any additional information is received, a supplemental report will be filed.
Additional Manufacturer Narrative
In previous report b5 verbiage, adverse event/product problem, type of reported complaint and reporting address line 1 captured incorrectly.It has been corrected in this report.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 that the patient alleging bladder cancer.There was no report of medical intervention.The manufacturer was made aware of this complaint through a representative of the customer.The device has not been returned to the manufacturer.At this time, no further investigation can be performed at this time.If any additional information is received, a supplemental report will be filed.In box b: adverse event/product problem has been corrected.In box e: reporting address city, reporting address state has been corrected.In box h: type of reported complaint, patient outcome code grid and health impact grid has been corrected.

• Brand Name: REMSTAR PLUS
• 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: 22121554
• Report Number: 2518422-2025-046017
• Device Sequence Number: 17180946
• Product Code: BZD
• UDI-Device Identifier: 00606959028647
• UDI-Public: (01)00606959028647
• 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,Followup
• Report Date (Section B): 06/06/2025

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: 260P
• Device Catalogue Number: 260P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2014
• 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