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

Model Number IN251S

Device Problem Degraded (1153)

Patient Problems Arrhythmia (1721); Unspecified Kidney or Urinary Problem (4503); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/02/2024

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 diabetes, chronic kidney disease and heart arrhythmia.No medical intervention was specified by the patient.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 exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : device not returned to manufacturer.

• Brand Name: REMSTAR PLUS 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: 18727509
• MDR Text Key: 335701511
• Report Number: 2518422-2024-08127
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IN251S
• Device Catalogue Number: IN251S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2013
• 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): Other