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

Model Number	DS560TBT
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleges seeing white powder or residue on black filter.There was no allegation of 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 received information alleging an issue related to a cpap device's sound abatement foam.The patient previously alleges seeing white powder or residue on black filter.There was no allegation of harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.During an external and internal inspection, the manufacturer observed that a non-philips inlet air filter was installed in the air filter area.The air outlet port had light brown, dust-like contamination and tiny fibers/hairs on it.A film of unknown residue was present on the inside of the top cover and on the display window.A few hairs/fibers were also found on the non-philips air input filter.Dust contamination and hairs/fibers were observed on the top of the device beneath the rotary knob.The printed circuit assembly (pca) had dust-like contamination on its surface, particularly around the user interface (ui) rotary switch.Dust-like contamination was present on the top of the blower box lid and in the surrounding area.Unknown residue was found under the blower box lid, and the blower box contained dust contamination.The sound abatement foam was intact but showed light dust contamination.The air inlet seal was yellowed and had white, dust-like contamination on it.Dust-like contamination and hairs/fibers, along with two pieces of brown, unknown contamination, were present inside the bottom enclosure.The blower motor had a spot of unknown liquid contamination, indicating potential liquid ingress, and also showed dust contamination inside the motor.Evidence of sound abatement foam degradation/breakdown was not observed in this device.The manufacturer used a fitt (foam integrity test tool) and was not able to confirm the presence of degraded sound abatement foam.The device's downloaded logs were reviewed by the manufacturer.There were 32 errors found.The manufacturer concludes there was no evidence of sound abatement foam degradation in the device and was able to confirm the customer's complaint.The manufacturer can confirm the presence of multiple contaminants that are not consistent with degraded sound abatement foam.Sections d8, d9, h2, h3, h6 has been updated in this report.

• Brand Name: REMSTAR AUTO
• 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: rosko melissa ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 13623645
• Report Number: 2518422-2022-06380
• Device Sequence Number: 5186825
• Product Code: BZD
• UDI-Device Identifier: 00606959042858
• UDI-Public: 00606959042858
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: DS560TBT
• Device Catalogue Number: DS560TBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2015
• 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: 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