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

Model Number DS460TS

Device Problems Degraded (1153); Leak/Splash (1354); Decrease in Pressure (1490)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned.

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 an issue related to a remstar pro c-flex+ device's sound abatement foam.The patient has alleged visualization of particles.There was no report of serious or permanent harm or injury.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported 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 an issue related to a remstar pro c-flex+ device's sound abatement foam.The patient has alleged visualization of particles.There was no report of serious or permanent harm or injury.Additional information received from the patient indicated that the patient stopped using the device when the pressure failed and when they awoke there was film of "lubricant or oil" along with black particulates in the hose and mask.The patient reports cleaning the mask and hose with soap and water weekly.Section h6 device problem code, infusion or flow problem and mechanical problem.

• Brand Name: REMSTAR PRO C-FLEX+
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17882362
• MDR Text Key: 325076623
• Report Number: 2518422-2023-25704
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005846
• UDI-Public: 00606959005846
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS460TS
• Device Catalogue Number: DS460TS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1