MAUDE Adverse Event Report: RESPIRONICS, INC REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	561CA
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.There was no report of patient harm or injury this issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
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 previously received information alleging visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury.After the third attempt to have the device and components returned for evaluation, the customer declined to respond to the gfe related questions and terminated the call.The manufacturer is submitting a follow-up report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this follow-up report will be filed.
Additional Manufacturer Narrative
The remstar auto a-flex device was returned to a third-party service center for further evaluation.During evaluation, the device was found to be functional.Sound abatement foam degradation was not observed.There was no evidence of foam degradation or particles found in the assembly.The device did not contain any type of contamination the service center also retrieved and reviewed the device's error logs.There were 7 errors found.The third-party service center could not confirm the customer's allegation and there was no visible foam degradation.The unit was scrapped after device evaluation was completed.Sections g1, h2, h3, and h6 have been updated in this report.

• Brand Name: REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7243512041
• MDR Report Key: 12714217
• Report Number: 2518422-2021-05898
• Device Sequence Number: 11938032
• Product Code: BZD
• UDI-Device Identifier: 00606959030527
• UDI-Public: 00606959030527
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 561CA
• Device Catalogue Number: 561CA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 06/27/2023; 07/31/2025
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 06/28/2023; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2015
• 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
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown