MAUDE Adverse Event Report: RESPIRONICS, INC. DREAM STATION 2 AUTO CPAP ADVANCED; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problems Disconnection (1171); Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 05/14/2022

Event Type  Death  

Event Description

Disabled son had cpap machine replaced due to recall.Received replacement machine on monday.Used it on friday night.Found son dead saturday morning.Hose had disconnected from mask.Hose should have locking connector not slip on.Fda safety report id# (b)(4).

• Brand Name: DREAM STATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 14854020
• MDR Text Key: 295033644
• Report Number: MW5110561
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959062733
• UDI-Public: (01)00606959062733
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX520H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: KEPPRA; VIMPAT
• Patient Outcome(s): Death
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 154 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White