MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTARPROC-FLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DS460HBT
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
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 sound abatement foam.The patient has alleged visualization of particles.There was no report of serious or permanent harm or injury.The device was returned to a third-party service centre.The device evaluation has been completed, and evidence of sound abatement foam degradation/breakdown was not observed in the base unit.During the evaluation, secondary findings, dust was observed, and complaint was not confirmed.The device was corrected.The third-party service centre conclude that evidence of sound abatement foam degradation/breakdown was not observed but dust contamination in the air path was observed.The device was corrected.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: REMSTARPROC-FLEX+
• 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: 21650935
• Report Number: 2518422-2025-037737
• Device Sequence Number: 9245880
• Product Code: BZD
• UDI-Device Identifier: 00606959024199
• UDI-Public: (01)00606959024199
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DS460HBT
• Device Catalogue Number: DS460HBT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2015
• 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
• Patient Sex: Unknown