MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PLUS CFLEX; K131982

Model Number IT261S

Device Problem Degraded (1153)

Patient Problems High Blood Pressure/ Hypertension (1908); Sleep Dysfunction (2517)

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer.

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 that the patient complains of insomnia and sudden changes in blood pressure.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: REMSTAR PLUS CFLEX
• Type of Device: K131982
• 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: 17902356
• MDR Text Key: 325233000
• Report Number: 2518422-2023-26050
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959049512
• UDI-Public: 00606959049512
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• 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: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IT261S
• Device Catalogue Number: IT261S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2018
• 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