MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number UDSX500S11F

Device Problem Unexpected Shutdown (4019)

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888)

Event Date 01/03/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a dreamstation auto cpap device.The patient has alleged gasping for air and the machine was off.Once she removed his mask blood came out of his mouth and his feeding tube.Medical intervention was specified that, he was transported to a local hospital and patient is currently in the hospital due to his machine shutting off.Physician are saying that the device caused the pulmonary hemorrhage by suffocation.The device was returned to a third-party service center.The technician was not confirmed particles in the air path during the device evaluation.  the manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 18134678
• MDR Text Key: 328083704
• Report Number: 2518422-2023-30199
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UDSX500S11F
• Device Catalogue Number: UDSX500S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 20 YR
• Patient Sex: Male