MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION C-PAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DREAMSTATION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arrhythmia (1721); Headache (1880); Viral Infection (2248); Low Oxygen Saturation (2477); Unspecified Immune System Problem (4435); Unspecified Respiratory Problem (4464)

Event Date 06/01/2021

Event Type  Injury  

Event Description

I am not certain of the cause of my hospitalization stay of 1 week, however, i use this philips dreamworks c-pap and i went from perfectly healthy and exercising daily to sick in the hospital for breathing problems, high heart rate, low oxygen level and compromise immune system.An infectious diseases dr.Had to be called in.After i was better i requested hospital discharge but did not find out until 3 days later, after them taking blood to study several times and 1 mean several times that the infectious disease.Dr.Diagnosed me with cmv virus which is very uncommon with adults usually seen with case of a depicted immune system from an organ transplant.That was a long sentence explanation.My personal dr.Was amazed as to what happened to me.What caused this total breakdown.My blood plantlet count has never returned to normal, however it was satisfactorily high enough for a dr.To do hop replacement surgery 2 months ago.I would be happy to talk with an agent about my episode.I had struggled with the c-pap machine for months with nasal congestions and lung breathing problems and headaches,.My dr prescribe steroids, breathing inhalers and allergy pills.And was monitoring before my hospitalization.(b)(6).

• Brand Name: PHILIPS DREAMSTATION C-PAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15301404
• MDR Text Key: 298833146
• Report Number: MW5111734
• 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: Patient
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/21/2017
• Device Model Number: DREAMSTATION
• Device Catalogue Number: AUTOCPAPHUMC
• Device Lot Number: DSX500H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLERGY PILLS; ALLOPURINOL
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Race: White