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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS DREAMSTATION CPAP MACHINE
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PHILIPS RESPIRONICS DREAMSTATION CPAP MACHINE Back to Search Results
Model Number DSX500T11C
Device Problems Use of Incorrect Control/Treatment Settings (1126); Communication or Transmission Problem (2896)
Patient Problem Sleep Dysfunction (2517)
Event Date 11/02/2017
Event Type  malfunction  
Event Description
I was diagnosed with sleepapnea in late (b)(6) 2017 and prescribed an auto cpap (b)(6).The medical device, phillips dreamstation is accessed via the (b)(6) by the doctor to titrate parameters and get feedback on sleep data.This cpap machine's (b)(6) modem doesn't communicate with the home's router/modem due to network band incompatibility as determine by phillips' technical rep on or about (b)(6) 2017.My home network band is 5 ghz vs 2.4 ghz for the cpap's (b)(6) modem.My internet provider, (b)(6), stated that 2.4 ghz is the old network band, no longer supported.Currently, i cannot fall asleep with the cpap due to high starting pressure and the doctor cannot change the setting due to the communication issues described above.
 
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Brand Name
DREAMSTATION CPAP MACHINE
Type of Device
DREAMSTATION CPAP MACHINE
Manufacturer (Section D)
PHILIPS RESPIRONICS
MDR Report Key7179053
MDR Text Key96978690
Report NumberMW5074508
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDSX500T11C
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/09/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
Patient Weight108
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