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

Model Number	AH560HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The capa process identified complaints not being created for quality issues found during third party servicing.Based on a review of records impacted by the identified issue, it was determined that this record needed to be corrected and is now being submitted accordingly.
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.A remstar auto a-flex device was returned to a third-party service center with no initial alleged complaint.During the evaluation of the device at the third-party service center, the device was visually inspected, and no foam particles were noted in the airpath, yet foam degradation was noted.The devices sound abatement foam was replaced to address the issue.Additionally, the service technician also found the evaluation of the device data identified unrelated error codes.These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements.No evidence was identified to suggest that these error codes contributed to or caused the reported event.The device was scrapped by the service center after the evaluation was completed.
Additional Manufacturer Narrative
This notification was initiated to evaluate a returned device in relation to the sound abatement foam recall.During the review, it was identified that an incorrect blfm (blower foam) code had been entered in trackwise (tw).A review of the source documentation in sap confirmed that the blfm code was applied in error.The associated complaint information was further assessed and confirmed that no death or serious injury was reported in connection with this event.Additionally, there is no evidence of a malfunction that would be likely to lead to death or serious injury if it were to recur.Based on the available information and in accordance with applicable regulatory reporting requirements, this event does not meet the criteria for reportability to any regulatory authority.Therefore, no regulatory reporting is required at this time.

• Brand Name: REMSTAR AUTO A-FLEX
• 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 ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24537265
• Report Number: 2518422-2026-008440
• Device Sequence Number: 8971754
• Product Code: BZD
• UDI-Device Identifier: 00606959005860
• UDI-Public: (01)00606959005860
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: AH560HS
• Device Catalogue Number: AH560HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2015
• 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: Reuse
• 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