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

Model Number	557P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (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 previously received information alleging an issue related to a cpap device's sound abatement foam.The patient had alleged to have black particles in the pipeline.There was no report of patient harm or injury.The device was returned to a third-party service center for investigation.Upon receipt, the device was found to have recorded 19451.1 blower hours and 16987 machine or operation hours.During the evaluation of the device at the service center, the device log files were successfully downloaded and reviewed in full.No actionable errors were identified in the log files.In addition, there was no evidence of foam particles or degradation.The customer complaint was not confirmed.The device was scrapped.The manufacturer has updated h6 in this report.

• Brand Name: REMSTAR AUTO AFLEX ASSY
• 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: 12955930
• Report Number: 2518422-2021-07745
• Device Sequence Number: 4715187
• Product Code: BZD
• UDI-Device Identifier: 00606959039612
• UDI-Public: 00606959039612
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 557P
• Device Catalogue Number: 557P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2012
• 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