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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; OXYGEN CONCENTRATOR
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DEVILBISS HEALTHCARE LLC DEVILBISS; OXYGEN CONCENTRATOR Back to Search Results
Model Number 525DS
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
During a retrospective complaint review, devilbiss healthcare identified an oxygen concentrator with complaint of "has no alarm or light panel function." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Devilbiss evaluated the unit and found the root cause of the complaint to be a damaged front cover and the pc board not operating to specification.The cover and pc board were replaced, and the unit operated to specification.
 
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Brand Name
DEVILBISS
Type of Device
OXYGEN 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 Key15079280
MDR Text Key304218880
Report Number2515872-2022-00100
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 Distributor
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number525DS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Date Manufacturer Received11/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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