MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR SYSTEM ONE 60 SERIES; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AU561TS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
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.The patient alleged visualization of black particles coming up out of the mouthpiece, and fine peppery black particles when blowing their nose.The patient stated they are "having a nose operation due to the black particles picked up by the specialist patient only noticed the black particles when it started appearing on the handkerchief and patient assumed it might have been the filter".The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental follow-up report will be submitted when the manufacturer's investigation is complete.
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 patient alleged visualization of black particles coming up out of the mouthpiece, and fine peppery black particles when blowing their nose.The patient stated they are "having a nose operation due to the black particles picked up by the specialist patient only noticed the black particles when it started appearing on the handkerchief and patient assumed it might have been the filter".The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was confirmed.During evaluation of the device, there was evidence of the sound abatement foam degradation/breakdown observed on the outside and inside of the blower box, inside the blower motor, and at the bottom of the enclosure were visible and moist.There were large pieces of sound abatement foam missing from the formation.Additional findings not related to the malfunction were eight errors that were logged, dust-like contamination at the air outlet, on the printed circuit assembly (pca), in the blower, and throughout the inside enclosure.In addition, the user interface knob and air inlet filter were missing on the device.There was possible corrosion on the water tank pan and potential mineral deposits inside the water tank.

• Brand Name: REMSTAR SYSTEM ONE 60 SERIES
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 20372521
• Report Number: 2518422-2024-101540
• Device Sequence Number: 3796043
• Product Code: BZD
• UDI-Device Identifier: 00606959005488
• UDI-Public: (01)00606959005488
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

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: AU561TS
• Device Catalogue Number: AU561TS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2015
• 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
• 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