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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS SYSTEM ONE CPAP MACHINE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS SYSTEM ONE CPAP MACHINE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING Back to Search Results
Model Number SYSTEM ONE
Device Problem Nonstandard Device (1420)
Patient Problems Chest Pain (1776); Dyspnea (1816); Headache (1880); Unspecified Infection (1930); Inflammation (1932); Vomiting (2144); Dizziness (2194); Unspecified Eye / Vision Problem (4471); Renal Impairment (4499)
Event Date 07/16/2021
Event Type  Injury  
Event Description
I use a phillips cpap machine for sleep apnea and was informed by my medical equipment supplier by email on (b)(6) 2021 that my cpap machine was part of the recall.I have used a cpap machine every night since 1997.I have symptoms of recurring sinus infections, inflammation, chest pain, shortness of breath, tightness in my chest, headaches, eye issues, liver and kidney issues, heart palpitations, dizziness, nausea and vomiting.I am going to make an appointment to see my primary care doctor to discuss my symptoms.Fda safety report id # (b)(4).
 
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Brand Name
PHILIPS RESPIRONICS SYSTEM ONE CPAP MACHINE
Type of Device
VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
Manufacturer (Section D)
PHILIPS / RESPIRONICS, INC.
MDR Report Key12202652
MDR Text Key262900318
Report NumberMW5102646
Device Sequence Number1
Product Code MNS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/16/2021
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
Device Model NumberSYSTEM ONE
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/20/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age60 YR
Patient Weight82
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