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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; CONCENTRATOR
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DEVILBISS HEALTHCARE LLC DEVILBISS; CONCENTRATOR Back to Search Results
Model Number 525DS
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by a provider, who stated that they "had a power surge and unit sparked." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.
 
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Brand Name
DEVILBISS
Type of Device
CONCENTRATOR
Manufacturer (Section D)
DEVILBISS HEALTHCARE LLC
100 devilbiss drive
somerset PA 15501
Manufacturer (Section G)
DEVILBISS HEALTHCARE LLC
100 devilbiss drive
somerset PA 15501
Manufacturer Contact
jillian forster
99 seaview blvd
ste 210
port washington, NY 11050
5169984600
MDR Report Key16694456
MDR Text Key312865091
Report Number2515872-2023-00022
Device Sequence Number1
Product Code CAW
UDI-Device Identifier00885304000846
UDI-Public885304000846
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 Health Professional
Reporter Occupation Other
Remedial Action Inspection
Type of Report Initial
Report Date 04/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number525DS
Was Device Available for Evaluation? No
Date Manufacturer Received03/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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