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

Model Number DS960TS

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Headache (1880); Nausea (1970); Dizziness (2194); Balance Problems (4401)

Event Date 12/21/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to bipap device's sound abatement foam.The patient alleges to have asthma, headaches, dizziness, nausea, and unsteadiness.There is no report of medical intervention being required.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

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 previously received information alleged to have asthma, headaches, dizziness, nausea, and unsteadiness related to a bipap device's sound abatement foam.There is no report of medical invervention being required.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 updated in this report.

• Brand Name: BIPAP AUTOSV ADV
• 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 15206 ; 2673970028
• MDR Report Key: 13659843
• MDR Text Key: 286505555
• Report Number: 2518422-2022-08858
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959012530
• UDI-Public: 00606959012530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS960TS
• Device Catalogue Number: DS960TS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2015
• 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 Outcome(s): Other