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

Model Number	FR568S
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2024
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
A device was returned to a third-party service center in relation to the voluntary field safety notice and recall notification involving the sound abatement foam used in certain cpap, bipap, and mechanical ventilator devices.During the evaluation, the service center conducted a visual inspection and observed evidence of foam degradation, including the presence of dust within the device.The device powered on successfully, and airflow functionality was verified.The device's downloaded logs were reviewed by the third-party service center.There were three error codes found.The third-party service center reported that they could not confirm the customer's allegation.However, they confirmed visible foam degradation and dust within the device.The unit was scrapped.

• Brand Name: REMSTAR AUTO P-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: 24673198
• Report Number: 2518422-2026-111168
• Device Sequence Number: 13287249
• Product Code: BZD
• UDI-Device Identifier: 00606959030978
• UDI-Public: (01)00606959030978
• 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: Foreign,Company Representative
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: FR568S
• Device Catalogue Number: FR568S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2024
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2013
• 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