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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEVEL 1; HOTLINE LOW FLOW SYSTEM
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LEVEL 1; HOTLINE LOW FLOW SYSTEM Back to Search Results
Catalog Number CON-HL-90
Device Problem Failure to Power Up (1476)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received that device is not powering on.No adverse effects reported.
 
Manufacturer Narrative
Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.Visual inspection revealed that the float switch was stained red, the pcb power switch and retainer required an upgrade, the enclosure was stained and marked.The front cover and reservoir cover were both cracked, the line cord was worn and the pole clamp was damaged.The investigator subsequently filled the tank with water, attached a temperature fixture, plugged in the line cord, and turned on the power switch.The customer reported product problem (failure to power on) was confirmed during testing.The product problem occurred because of a defective pcb and power switch.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was a design issue.This was established as the root cause.The outdated pcb was replaced in order to correct the problem.
 
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Brand Name
LEVEL 1
Type of Device
HOTLINE LOW FLOW SYSTEM
MDR Report Key10195540
MDR Text Key196437687
Report Number3012307300-2020-06240
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/02/2020
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 No Information
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/25/2020
Supplement Dates Manufacturer Received08/05/2020
Supplement Dates FDA Received09/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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