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

Model Number DS950HS

Device Problem Degraded (1153)

Patient Problems Headache (1880); Dizziness (2194); Unspecified Respiratory Problem (4464)

Event Date 01/16/2024

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 bipap autosv adv system device's sound abatement foam.The patient's attorney reporting allegations of nose irritation; dizziness and/or headache.No other clinical information or medical interventions were reported.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.

Manufacturer Narrative

In previous report manufacturer reported an issue related to a bipap autosv adv system device's sound abatement foam.The patient's attorney reporting allegations of nose irritation; dizziness and/or headache.No other clinical information or medical interventions were reported.In previous report manufacturer incorrectly mark 'serious injury' in h1 (type of reported complaint) section.There was no report of serious or permanent patient harm or injury.In this report h1 (type of reported complaint) section corrected/updated as product problem.

• Brand Name: BIPAP AUTOSV ADV SYSTEM
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19174885
• MDR Text Key: 340953082
• Report Number: 2518422-2024-20745
• Device Sequence Number: 1
• Product Code: MNS
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

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: DS950HS
• Device Catalogue Number: DS950HS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2012
• 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