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

Model Number DS460HS

Device Problem Degraded (1153)

Patient Problems Airway Obstruction (1699); Asthma (1726); Pneumonia (2011); Rash (2033); Respiratory Tract Infection (2420); Skin Tears (2516); Unspecified Respiratory Problem (4464)

Event Date 07/31/2023

Event Type  Injury  

Event 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 water was backing up through the tube and would wake the patient from almost drowning.The patient followed the physician's orders to change the level/placement of the device and issue continued at all levels.The patient states their asthma started flaring up more and had continuous upper respiratory infections.The patient reports their skin started breaking out to the point where their feet and hands would be "rare".The patient states they awoke one morning with a hole in their right breast that no one could explain.Patient has been experiencing lung issues and pneumonia often.The patient is not sure if particles/residue were seen in the device.The patient started using the device in 2018 and cleans the tubing with sterile water, then hangs it over the shower rod to air dry every morning.The device was last used by the patient in (b)(6) 2021.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.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: REMSTAR PRO C-FLEX+
• Type of Device: 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: 17604207
• MDR Text Key: 321754246
• Report Number: 2518422-2023-20585
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005839
• UDI-Public: 00606959005839
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS460HS
• Device Catalogue Number: DS460HS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening