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

Model Number	DS250HS
Medical Device Problem Codes	Degraded (1153); Device Emits Odor (1425)
Health Effect - Clinical Codes	Dyspnea (1816); Cough (4457); Epistaxis (4458); Unspecified Respiratory Problem (4464)
Date of Event	09/20/2021
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 the device was burning plastic type of smell, and the visualization of particles in tubing / chamber and particles in airway from the device.The patient alleges losing air pressure in the device causing difficulty breathing, nasal irritation and bloody nose, coughing, and a lot of mucus.Medical intervention was not specified.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 manufacturer.

• Brand Name: REMSTAR PLUS 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18578397
• Report Number: 2518422-2024-04275
• Device Sequence Number: 7923629
• Product Code: BZD
• UDI-Device Identifier: 00606959046375
• UDI-Public: 00606959046375
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DS250HS
• Device Catalogue Number: DS250HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2010
• 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
• Patient Sex: Unknown