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

Model Number "DSX500S11"

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776)

Event Date 10/23/2020

Event Type  Injury  

Event Description

Experience chest pain while breathing, pain increased if taking deep breaths, went to (b)(6) hospital emergency room.Diagnosed with pulmonary embolisms.No apparent cause could be determined.

• Brand Name: PHILIPS DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC
• MDR Report Key: 12771225
• MDR Text Key: 280545977
• Report Number: MW5105160
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: "DSX500S11"
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 MG ; CENTRUM SILVER; ELIQUIS 5 MG X 2 DAILY; FISH OIL 1200 MG ; OMEPRAZOLE 20 MG ; PRAVASTATIN 40 MG ; TAMSULOSIN 0.4 MG
• Patient Outcome(s): Disability; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White