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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DEX500S13
Device Problems Corroded (1131); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2023
Event Type  malfunction  
Event Description
The manufacturer received information in relation to a dreamstation auto cpap unit.The device was returned to third party service center.The service center reports the unit's power cord is corroded and the device cannot be powered on in order to be able to collect the error log/machine hours.During the evaluation of the device at the third party service center, the device was visually inspected and corrosion was found on metallic surfaces.Additionally, contamination of dust/dirt was found on the inside of the device.The device was scrapped.
 
Manufacturer Narrative
H3 other text : third party service center.
 
Manufacturer Narrative
The manufacturer received information in relation to a dreamstation auto cpap unit.The device was returned to third party service center.The service center reports the unit's power cord is corroded and the device cannot be powered on in order to be able to collect the error log/machine hours.During the evaluation of the device at the third party service center, the device was visually inspected and corrosion was found on metallic surfaces.Additionally, contamination of dust/dirt was found on the inside of the device.The device was scrapped.Analysis of past events has not indicated an adverse event has occurred due to corrosion.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.Additionally, the risk file indicates that corrosion will not substantially affect the performance of the device.This complaint is considered not reportable.
 
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Brand Name
DREAMSTATION AUTO CPAP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key17775772
MDR Text Key323757593
Report Number2518422-2023-23737
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K131982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
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 Other
Device Model NumberDEX500S13
Device Catalogue NumberDEX500S13
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/08/2023
Initial Date FDA Received09/19/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/13/2020
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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