MAUDE Adverse Event Report: RESPIRONICS, INC REMSTAR PRO C-FLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	461CA
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Chest Pain (1776); Headache (1880); High Blood Pressure/ Hypertension (1908); Dizziness (2194); Respiratory Tract Infection (2420)
Date of Event	09/05/2021
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.The patient alleged high blood pressure, headache, sinus infection, chest heaviness and dizziness.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Additional information was received on nov 25, 2024 and section h11 should be reported as: 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 an issue related to a cpap device's sound abatement foam.The patient alleged high blood pressure, headache, sinus infection, chest heaviness and dizziness.Medical intervention was not specified.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacture inspected externally and internally, observed an unknown dust contaminant on the top cover, inside of the iso port, pca, side panel, blower cap, right side assembly, blower, blower housing, bottom enclosure, and air inlet seal.They observed black hairlike contaminant on the top cover, pca, side panel, right side assembly, and bottom enclosure.Evidence of sound abatement foam degradation/ breakdown was not observed.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 event logs were downloaded and reviewed by manufacturer.The manufacturer found two error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes that they were not able to confirm the customer complaint and unable to directly address the patients' symptoms.There was no visible damage or functionality failures of the device.The manufacturer observed dust/dirt contamination in the device and are consistent with being from an external source.Sections d8, d9, h2, h3, h6 has been updated in this report.
Additional Manufacturer Narrative
The sections b1, b2, h1 and h6 have been corrected in this report as follows: section b1 was corrected to product problem.(in the previous mdr both adverse events and product problem was checked.) section b2 was corrected to blank.( previously, it was other serious or important medical events.) section h1 was changed from serious injury to malfunction.Section h6 health effects - impact code was corrected.

• Brand Name: REMSTAR PRO C-FLEX+
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer Contact: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 15111844
• Report Number: 2518422-2022-65329
• Device Sequence Number: 4149392
• Product Code: BZD
• UDI-Device Identifier: 00606959030138
• UDI-Public: 00606959030138
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2024

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: 461CA
• Device Catalogue Number: 461CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2021
• Supplement Date Received by Manufacturer: 11/25/2024; 12/04/2024
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 11/28/2024; 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2013
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown