MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS 1; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Granuloma (1876); Liver Damage/Dysfunction (1954); Pain (1994); Cancer (3262)

Event Date 03/01/2020

Event Type  Injury  

Event Description

Lung cancer (diagnosed in (b)(6) 2020).Lung disease (granulomatis diagnosed in (b)(6) 2020).Liver disease (diagnosed in 2007).First machine (philips respironics 1) (got it in 2004) (this is the machine in question), diagnosed with the lung cancer in (b)(6) 2020.It has caused him severe pain.

• Brand Name: PHILIPS RESPIRONICS 1
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13289673
• MDR Text Key: 284148555
• Report Number: MW5106745
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/18/2022

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 Expiration Date: 01/01/2009
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2022
• Patient Sequence Number: 1
• Treatment: LEVITRAZENE; MATOLUCUS ; METROPROLOL
• Patient Outcome(s): Disability; Other; Required Intervention; Hospitalization; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White