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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 Problems No Audible Alarm (1019); Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
During a retrospective complaint review, devilbiss healthcare examined a complaint received from a distributor on august 21, 2019 involving a devilbiss oxygen concentrator stating that the unit "randomly powers down, no alarm." the root cause investigation revealed that the line cord was defective.The information received at the time did not indicate whether the defect was the result of damage or misuse, such as impingement.There was no report or evidence of illness, injury or medical treatment associated with the complaint.
 
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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 blcd.
port washington, PA 11050
5169984600
MDR Report Key14787494
MDR Text Key294581557
Report Number2515872-2022-00050
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 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2022
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 Manufacturer09/24/2019
Date Manufacturer Received08/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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