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

Model Number	260P
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Inflammation (1932); Pulmonary Dysfunction (2019); Unspecified Respiratory Problem (4464)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
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 manufacturer was made aware of this complaint through a representative of the customer alleging of nose irritation, respiratory tract irritation, inflammatory response, reduced cardiopulmonary reserve related to a cpap device's sound abatement foam.No medical intervention was specified.The manufacturer's investigation is ongoing.A 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 manufacturer was made aware of this complaint through a representative of the customer alleging of nose irritation, respiratory tract irritation, inflammatory response, reduced cardiopulmonary reserve related to a cpap device's sound abatement foam.No medical intervention was specified.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed pil initiated therapy with the device and verified airflow, using a pil supplied power supply and ac power cord.Pil also observed customers humidifier heater plate did heat.Pil observed there was sound abatement foam degradation in the following areas.Black substance, consistent with sound abatement foam degradation, was observed on the outside bottom of the blower box and was stuck to it.Tiny black pieces of a black substance, consistent with sound abatement foam degradation, were found on the bottom of the enclosure.Pil was able to confirm the presence of degraded sound abatement foam in the device secondary findings - pil observed the following from an external and internal inspection: ui (user interface) knob missing the air outlet port had dust-like contamination in it, white dust-like contamination at the air inlet, pca (printed circuit assembly) had dust-like contamination all over the top of it, dust-like contamination on top of the blower box and throughout the bottom of the enclosure, dust-like contamination on top of the blower motor, dust-like contamination in the bottom of the blower box, air inlet seal had yellowed and had dust-like contamination on it, sound abatement foam had dust-like contamination on it.Pil can confirm the presence of multiple contaminants that are not consistent with degraded sound abatement foam from the secondary findings and there was no error code found.Pil observed the following from an internal and external inspection of humidifier pil observed the flip lid seal had unknown dark contamination on it.Unknown white and tan dust-like and hair-like contamination, throughout humidifier enclosure.Unknown white and tan dust-like contamination on and under the heater plate.Unknown white dust-like contamination on the dry box seals.Potential mineral deposits inside the water tank.Unknown white and tan dust-like contamination in the iso port (international organization of standardization).The contamination found in the humidifier enclosure is considered not to be in the airpath.In box h: (device) problem code grid, evaluation method code grid, evaluation results code grid and conclusion code grid has been updated.In box g: device evaluated by mfg? has been updated.In box d; device avail.For eval? and date returned has been updated.

• Brand Name: REMSTAR PLUS
• 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: 22121604
• Report Number: 2518422-2025-046053
• Device Sequence Number: 11805085
• Product Code: BZD
• UDI-Device Identifier: 00606959028647
• UDI-Public: (01)00606959028647
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 260P
• Device Catalogue Number: 260P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2014
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown