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

Model Number DS960HS

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Headache (1880); Inflammation (1932); Dizziness (2194); Unspecified Respiratory Problem (4464)

Event Date 08/21/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

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, dizziness, headaches, asthma, and inflammatory response.The manufacturer was made aware of this complaint through a representative of the customer.No other information has been received, however, if additional information is received a supplemental/follow up will be sent.

• 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 15208 ; 4125423300
• MDR Report Key: 17720758
• MDR Text Key: 323092283
• Report Number: 2518422-2023-22283
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959012523
• UDI-Public: 00606959012523
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DS960HS
• Device Catalogue Number: DS960HS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening