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

Model Number	FR565S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
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 visible foam particles were observed.The device was scrapped.
Additional Manufacturer Narrative
Conclusion code grid was incorrect in the previous report.In this report it has been corrected and updated." the affected products with field complaints alleging pe-pur foam degradation have undergone the establishment of complaint codes specifically identifying foam degradation, for system one.A field correction action(2021-06-a) was initiated, and medical device recall letters were issued.A field action was initiated to replace pe-pur foam in affected products; degradation was added to the respective dfmeas and the risk management file ¿ 2203077 v27 (systemone) was updated to include hazards associated with foam degradation based on complaints analyzed through various health hazard evaluations (hhes).Risk tags ¿ degradation01, toxic02 and particulate01 reflect the safety risk of design containing the pe-pur foam.These complaints were monitored and trended in accordance with the complaint trending procedures.If the complaints were determined to meet the criteria for escalation, they were escalated for risk assessment through the post market clinical escalation process.As of the date of submission for this report, there is no indication that complaints for the failure in question have led to unacceptable levels of severity or probabilities of harm, and therefore no further action will be pursued.".

• Brand Name: REMSTAR AUTO A-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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 24764253
• Report Number: 2518422-2026-111853
• Device Sequence Number: 21144376
• Product Code: BZD
• UDI-Device Identifier: 00606959030725
• UDI-Public: (01)00606959030725
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: FR565S
• Device Catalogue Number: FR565S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2013
• 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