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

Model Number CA261NTS

Device Problems Degraded (1153); Unexpected Shutdown (4019)

Patient Problems Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464)

Event Date 10/29/2021

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 plus device's sound abatement foam.The patient has alleged runny nose, nasal/throat irritation or soreness and device will not turn on/device not functioning.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.

• 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 15208 ; 4125423300
• MDR Report Key: 18012181
• MDR Text Key: 326623481
• Report Number: 2518422-2023-27872
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030084
• UDI-Public: 00606959030084
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CA261NTS
• Device Catalogue Number: CA261NTS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2013
• 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