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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. PHILIPS DREAMSTATION CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS/RESPIRONICS, INC. PHILIPS DREAMSTATION CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
Philips started to replace cpap and bipap devices.They are not telling customers to move the removable modem over that was in the old machine to the new one.This results in loss of compliance monitoring since philips instructs the patients to send the old machine back (that contains a removable modem).The modems are expensive and hard to obtain.Our hospital system does not allow us to download a report from the sd card so patients are essentially out of luck in terms of obtaining a compliance report unless they physically go to the dme, but many dme's are in different states and just ship stuff to patients.Please tell philips they have to provide instructions specifically to move the removable modem over or make them replace the modems that were inadvertently sent back to philips.All they do currently is provide a manual for the new device, no specific instructions to move over the sd card, modem or humidifier.Fda safety report id #(b)(4).
 
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Brand Name
PHILIPS DREAMSTATION CPAP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS/RESPIRONICS, INC.
MDR Report Key15864896
MDR Text Key304423757
Report NumberMW5113474
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 11/22/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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