MAUDE Adverse Event Report: PHILIPS ELECTRONICS LTD. SYSYEM ONE CPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2023

Event Type  Injury  

Event Description

Diagnosed with interstitial lung disease by leading lung specialist.Review of scan by dr gerard criner, head temple lung center determined interstitial lung disease.

• Brand Name: SYSYEM ONE CPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS ELECTRONICS LTD.
• MDR Report Key: 16630609
• MDR Text Key: 312296898
• Report Number: MW5116041
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2023
• Patient Sequence Number: 1
• Treatment: DAILY MULTIVITAMIN ; FISH OIL
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White