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

Model Number DS1160TS

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 10/12/2023

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 respiratory tract irritation.Medical intervention was not specified.The manufacturer's investigation is ongoing.A supplemental 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
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18447384
• MDR Text Key: 332150133
• Report Number: 2518422-2024-00686
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959012592
• UDI-Public: 00606959012592
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS1160TS
• Device Catalogue Number: DS1160TS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1