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

Model Number DS260S

Device Problem Degraded (1153)

Patient Problem Eye Infections (4466)

Event Date 08/11/2021

Event Type  malfunction  

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 cpap device's sound abatement foam.The manufacturer received information alleging of eye irritation, eye infection.There was no report of serious or permanent patient harm or injury.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 on this device in mdr 2518422-2022-89274.This report was submitted as a duplicate report of the previously submitted report.

• Brand Name: REMSTAR PLUS
• 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 15206 ; 2673970028
• MDR Report Key: 15730443
• MDR Text Key: 305105413
• Report Number: 2518422-2022-90618
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005761
• UDI-Public: 00606959005761
• 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
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS260S
• Device Catalogue Number: DS260S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Male