MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTO AFLEX; 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	09/29/2021
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 black objects in the pipeline related to a cpap device's sound abatement foam.There was no report of patient harm or injury.After the first attempt to have the device and components returned for evaluation, customer could not able to provide the information about device return.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h6 is updated in this report.
Additional Manufacturer Narrative
The manufacturer was previously 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 black objects in the pipeline related to a cpap device's sound abatement foam.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 20375.8 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
• 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: 12625490
• Report Number: 2518422-2021-05202
• Device Sequence Number: 3451363
• Product Code: BZD
• UDI-Device Identifier: 00606959039612
• UDI-Public: 00606959039612
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 03/08/2023; 09/01/2023
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 04/19/2023; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2012
• 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