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	Dyspnea (1816); Respiratory Tract Infection (2420)
Date of Event	06/18/2021
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 patient alleges " has had multiple lung infections in the last few years and difficulty breathing".There is no allegation of permanent harm or injury.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
Additional Manufacturer Narrative
Additional information was received and section h 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 alleges " has had multiple lung infections in the last few years and difficulty breathing".There was no report of serious patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed dust/dirt contamination present on all surfaces of the base unit and humidifier base.The device did not return with an sd card.There is an unknown dust contaminate present at the iso port entrance and ui knob is not present.The base unit was found to have unknown dust/dirt/fiber contamination throughout the device internals.Moderate dust contamination was observed on device pca.The blower grommet, blower outlet bellows, blower housing, and air inlet seal appear discolored.The manufacturer was able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found 27 error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes, there was an evidence of sound abatement foam degradation and observed dust contaminant and was not able to confirm the complaint or address the symptoms specified.Box b1 was corrected to product problem.Box h1 was changed from serious injury to product problem.Box h6 health effects - impact code was corrected.Box h recall (z) number was wrongly captured in previously report and corrected in this report.Box d product udi was missed to capture in previously report and updated in this report.Device problem code grid, evaluation method code, evaluation results code and conclusion code grid has been updated.

• Brand Name: REMSTAR PRO C-FLEX +
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17497083
• Report Number: 2518422-2023-19248
• Device Sequence Number: 11398980
• Product Code: BZD
• UDI-Device Identifier: 00606959030138
• UDI-Public: (01)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): 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): 11/25/2024

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: 06/18/2021
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2012
• 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: Life Threatening
• Patient Sex: Unknown