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

Model Number	DS460HS
Medical Device Problem Codes	Degraded (1153); Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Pneumonia (2011); Cough (4457); Nasal congestion (4874)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This notification was opened due to an allegation from a patient stating, "the device is recalled and there was mold inside." the patient also reports they have gotten pneumonia a lot for which she would get a chest x-ray each time, saw 3 lung doctors, kept getting worse, and was diagnosed with copd.The patient also reported that her airway was blocked, and she has atrial fibrillation.She also had to have a heart valve replaced.The patient reported that she uses a nebulizer and rescue inhaler.She went to the hospital and was given "a syringe to clean out the stuff".The patient also reported coughing, congestion, has thyroid and lung nodules.She also has hypertension.The patient also reported a past medical history of sleep apnea.The patient reported using an ozone-based disinfection device.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.

• Brand Name: REMSTAR PRO C-FLEX+
• 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: 25411512
• Report Number: 2518422-2026-019611
• Device Sequence Number: 17574592
• Product Code: BZD
• UDI-Device Identifier: 00606959005839
• UDI-Public: (01)00606959005839
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113068
• 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
• Report Date (Section B): 06/05/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DS460HS
• Device Catalogue Number: DS460HS
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2014
• 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
• Usage of Device: Reuse
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female