MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AVAPS C-SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number CA1161XTS

Device Problem Degraded (1153)

Patient Problem Dyspnea (1816)

Event Date 07/19/2021

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 patient alleges shortness of breath after using device.There is no allegation of serious or permanent 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

H3 other text : device not returned to manufacturer.

• Brand Name: BIPAP AVAPS C-SERIES
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 18022385
• MDR Text Key: 327070244
• Report Number: 2518422-2023-27991
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959014060
• UDI-Public: 00606959014060
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA1161XTS
• Device Catalogue Number: CA1161XTS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Female