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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DSX500T11
Device Problems Crack (1135); Degraded (1153)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2023
Event Type  malfunction  
Event Description
A ventilator was returned to a third-party service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no allegation of serious or permanent harm or injury.During the evaluation of the device at the third-party service center, visualization of foam particles was observed.In addition, the device had rainbow scratches on the ui panel screen that were visible when powered on, cracks near the ambient sensor and loose therapy and ramp buttons on top enclosure.The ui panel, ambient sensor, and therapy and ramp buttons were replaced to resolve the issue.
 
Manufacturer Narrative
Device not returned to manufacturer.
 
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Brand Name
DREAMSTATION AUTO CPAP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
MDR Report Key18719598
MDR Text Key335697219
Report Number2518422-2024-07867
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
PMA/PMN Number
K131982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Remedial Action Recall
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberDSX500T11
Device Catalogue NumberDSX500T11
Was Device Available for Evaluation? No
Date Manufacturer Received03/13/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/08/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1974-2021
Patient Sequence Number1
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