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

Model Number 3935065

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Asthma (1726); Inflammation (1932); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Started using philips cpap dreamstation in 2008 then developed asthma in 2019, airway irritation and inflammation in 2019, irregular heartbeat around 2010, sinus infections in 2020.

• Brand Name: PHILIPS CPAP DREASTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13283894
• MDR Text Key: 284045206
• Report Number: MW5106716
• 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: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2013
• Device Model Number: 3935065
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CLONIDINE CL ; HYDROCHLOROTHIAZIDE ; SUDAFED ; VALSARTAN (325 MG); VERAPAMIL
• Patient Outcome(s): Disability; Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American