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

Model Number DS460S

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Nausea (1970); Vomiting (2144); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464)

Event Date 10/12/2023

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 an issue related to a remstar pro c-flex+ cpap device's sound abatement foam.The patient alleged respiratory tract irritation, nausea / vomiting, asthma, lung disease.No further clinical details or medical intervention were reported.Due to potential litigation surrounding this case, no follow up can be performed at this time.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device not returned to the 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19159451
• MDR Text Key: 340789894
• Report Number: 2518422-2024-21406
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005822
• UDI-Public: 00606959005822
• 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: Other,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

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS460S
• Device Catalogue Number: DS460S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2012
• 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
• Patient Outcome(s): Life Threatening