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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; REGULATOR,O2,MINI 0-15 L,870 CGA
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MEDLINE INDUSTRIES LP; REGULATOR,O2,MINI 0-15 L,870 CGA Back to Search Results
Catalog Number HCS8715M
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2022
Event Type  malfunction  
Event Description
According to the facility when the regulator was removed from the old oxygen tank and attached to the new oxygen tank a 'flash of flame came out when the oxygen was turned on'.
 
Manufacturer Narrative
According to the facility when the regulator was removed from the old oxygen tank and attached to the new oxygen tank a 'flash of flame came out when the oxygen was turned on'.Per the facility the oxygen was turned off immediately and a 'smell of burning filled the air'.According to the facility the green gasket on the regulator 'smelled of smoke and had a burn on the side'.No additional information is available.The sample is not available to be returned for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
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Type of Device
REGULATOR,O2,MINI 0-15 L,870 CGA
Manufacturer (Section D)
MEDLINE INDUSTRIES LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key14978270
MDR Text Key295640709
Report Number1417592-2022-00099
Device Sequence Number1
Product Code CAN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberHCS8715M
Was Device Available for Evaluation? No
Date Manufacturer Received06/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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