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

Model Number DREAMSTATION2 AUTO CPAP ADVANCED

Patient Problem Chest Pain (1776)

Event Type  Injury  

Event Description

Chest pain like pneumonia or heart attack, upon waking up after being on the machine for several hours.

• Brand Name: CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 18660967
• MDR Text Key: 334897333
• Report Number: MW5151141
• Device Sequence Number: 1
• Product Code: BZD
• 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
• Type of Report: Initial
• Report Date: 02/04/2024

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION2 AUTO CPAP ADVANCED
• Device Catalogue Number: DSX520T11C
• Device Lot Number: 2021-12-20
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2024