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

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Ptosis (2620); Cancer (3262); Epistaxis (4458); Localized Skin Lesion (4542); Nodule (4551)

Event Date 05/11/2021

Event Type  Death  

Event Description

Nosebleeds lasting hours.Cancer lesion at sinus location.Cancer in several locations of body including lungs and liver.Early reports of nodules in lungs.Drooping eyelid almost to closure until finally closed.Severe headaches.Too many to name over many months.Positive cancer and other problems.Too many prescriptions at death.Fda safety report id# (b)(4).

• Brand Name: PHILIPS DREAM STATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12583177
• MDR Text Key: 275168416
• Report Number: MW5104397
• Device Sequence Number: 1
• Product Code: BZD
• 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: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Disability
• Patient Age: 56 YR
• Patient Weight: 152