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

Model Number	LA261S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar plus cflex was returned to the manufacturer for evaluation to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The device was returned to the third-party service center for further evaluation.The device was evaluated.The device's downloaded logs were reviewed by the service center.There was no error code found.Upon further evaluation, visible foam particles were observed inside the blower kit.In conclusion, the customer's complaint was confirmed.The service center also found evidence of dust particles, cigarette smoke or insect infestations as contamination.The device was scrapped.There was no reported patient death or serious injury, however the reported issue/event is reportable due to the potential to cause or contribute to a serious injury as identified in capa (b)(4), in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.

• 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: 20762232
• Report Number: 2518422-2024-104505
• Device Sequence Number: 9292016
• Product Code: BZD
• UDI-Device Identifier: 00606959029910
• UDI-Public: (01)00606959029910
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K113068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: LA261S
• Device Catalogue Number: LA261S
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2014
• 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
• Patient Sex: Unknown