MAUDE Adverse Event Report: PHILIPS/RESPIRONICS INC. SYSTEM ONE CPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Headache (1880); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Began using philips systemone cpap (b)(6) 2015.Have had severe tachycardia (a-fib), frequent sinus infections, trouble breathing, headaches since using the cpap machine.

• Brand Name: SYSTEM ONE CPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 17228136
• MDR Text Key: 318289348
• Report Number: MW5118952
• Device Sequence Number: 1
• Product Code: MNS
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Treatment: ALBUTEROL.; AMBIEN.; ELIQUIS.; LOSARTAN.; METOPROLOL.
• Patient Outcome(s): Hospitalization; Life Threatening; Disability; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American