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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 Display Difficult to Read (1181)
Patient Problem No Patient Involvement (2645)
Event Date 07/14/2020
Event Type  malfunction  
Manufacturer Narrative
One fluid warmer was returned for evaluation.Visual inspection of the device found it to have a cracked water tank cover and loose pole clamp.A dhr review was performed subsequent to the manufacturing of the device and prior to its release; no problems were identified during this dhr review.Device tank was filled with water, and powered on-confirming the reported customer complaint.Issue was a result of a bad lcd/pcb and the problem source was determined to be unknown.
 
Event Description
Information was received that display is not working properly.Incident occurred during preventive maintenance; no patient involvement.
 
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Brand Name
LEVEL 1
Type of Device
HOTLINE LOW FLOW SYSTEM
Manufacturer (Section G)
NULL
MDR Report Key10397114
MDR Text Key202579227
Report Number3012307300-2020-08106
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 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
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 Manufacturer07/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2015
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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