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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL LEVEL 1; HOTLINE LOW FLOW SYSTEM
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NULL LEVEL 1; HOTLINE LOW FLOW SYSTEM Back to Search Results
Catalog Number CON-HL-90
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
One fluid warmer was returned for evaluation.Visual inspection of the device found it to have an outdated pcb and power switch, cracked enclosure and tank cover, and wear and tear damaged line cord and front cover.Device underwent functional testing by filling tank with water, attaching temperature check, plugged in line cord, and turning on power switch.The reported customer complaint has been confirmed, as a result of a burned out speaker on the pcb.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.The problem source has been unable to be confirmed.
 
Event Description
Information was received that speaker is not functioning-bad pcb.Incident occurred during preventive maintenance and no alarms sounded.
 
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Brand Name
LEVEL 1
Type of Device
HOTLINE LOW FLOW SYSTEM
Manufacturer (Section G)
NULL
MDR Report Key10138054
MDR Text Key194632705
Report Number3012307300-2020-05699
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/14/2020
Initial Date FDA Received06/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2010
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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