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

Model Number DS1060TS

Device Problem Degraded (1153)

Patient Problems Stroke/CVA (1770); Headache (1880)

Event Date 01/30/2023

Event Type  Injury  

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 device's sound abatement foam.The patient alleged headache and stroke.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP S/T
• 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: 16590000
• MDR Text Key: 311748916
• Report Number: 2518422-2023-07435
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959012561
• UDI-Public: 00606959012561
• 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: Consumer
• 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

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DS1060TS
• Device Catalogue Number: DS1060TS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2015
• 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): Other