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

Model Number DS1060HS

Device Problems Failure to Power Up (1476); Temperature Problem (3022)

Patient Problem Dyspnea (1816)

Event Date 05/04/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator is not functioning/will not turn on and a thermal issue.The customer alleges difficulty breathing/shortness of breath while using the device.The patient also stated they had a car accident due to falling asleep behind the wheel.Medical intervention was not specified.The customer was contacted on (b)(6) 2023 and stated the device is not putting out enough pressure.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: 18031674
• MDR Text Key: 326871773
• Report Number: 2518422-2023-28121
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959012554
• UDI-Public: 00606959012554
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DS1060HS
• Device Catalogue Number: DS1060HS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1