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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVILBISS HEALTHCARE DEVILBISS; OXYGEN CONCENTRATOR
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DEVILBISS HEALTHCARE DEVILBISS; OXYGEN CONCENTRATOR Back to Search Results
Model Number 525DS
Device Problems Defective Alarm (1014); Installation-Related Problem (2965)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/19/2018
Event Type  malfunction  
Event Description
We are filing a report to correct information filed in conjunction with mw5078532.We have contacted the homecare provider to locate and evaluate the device.The provider explained that a service call was made and the water container had to be removed and reinserted.The device is no longer with the end-user.There was no adverse event and the product is not malfunctioning.The end-user was not seriously injured while using this device.The medwatch report is in error.
 
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Brand Name
DEVILBISS
Type of Device
OXYGEN CONCENTRATOR
Manufacturer (Section D)
DEVILBISS HEALTHCARE
100 devilbiss drive
somerset PA 15501
Manufacturer (Section G)
DEVILBISS HEALTHCARE
100 devilbiss drive
somerset PA 15501
Manufacturer Contact
patricia beja
100 devilbiss drive
somerset, PA 15501
5169984600
MDR Report Key8033150
MDR Text Key127890235
Report Number2515872-2018-00006
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071397
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other
Type of Report Initial
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number525DS
Device Catalogue Number525DS
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/30/2018
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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