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

Model Number	AU461TS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Dyspnea (1816); Itching Sensation (1943)
Date of Event	07/12/2021
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 manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to experiencing an itchy throat/nose, difficulty breathing and asthma symptoms for a year.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.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 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 an issue related to a cpap device's sound abatement foam.The patient has previously alleged to experiencing an itchy throat/nose, difficulty breathing and asthma symptoms for a year.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.Despite of multiple attempts the device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.Previously submitted report was incorrectly filed as product problem which should have been filed as both product problem and serious injury.In this report, box b and box h has been updated correctly.
Additional Manufacturer Narrative
In this report, box b: adverse event or product problem (adverse event/product problem), box h: device manufacturers (health impact grid) has been corrected/updated.

• Brand Name: REMSTAR PROCFLEX+
• 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: 17128149
• Report Number: 2518422-2023-13510
• Device Sequence Number: 15298005
• Product Code: BZD
• UDI-Device Identifier: 00606959005457
• UDI-Public: (01)00606959005457
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/12/2025

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: AU461TS
• Device Catalogue Number: AU461TS
• 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: 07/12/2021
• Supplement Date Received by Manufacturer: 07/11/2025; 12/12/2025
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/11/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2015
• 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: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown