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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEVEL 1; HOTLINE LOW FLOW SYSTEMS
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LEVEL 1; HOTLINE LOW FLOW SYSTEMS Back to Search Results
Catalog Number CON-HL-90
Device Problem Electrical Shorting (2926)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
One fluid warmer was returned for evaluation.Visual inspection found a cracked enclosure and tank cover, wear and tear damaged line cord, front cover, and pole clamp, as well as outdated pcb and power switch.Device tank was filled with water, and powered on.The reported customer complaint was confirmed as device failed electrical testing.This was a result of a faulty pcb.However, the problem source has been determined to be unknown.
 
Event Description
Information was received that device is tripping the breaker/ above specs.No adverse effects reported.
 
Manufacturer Narrative
Other, other text: b5: updated with additional information.H6: patient code updated to reflect code 2645.
 
Event Description
Additional information was received indicating that there was no patient involvement.The product problem was observed during preventative maintenance.The device did not produce any alarms.
 
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Brand Name
LEVEL 1
Type of Device
HOTLINE LOW FLOW SYSTEMS
MDR Report Key11154141
MDR Text Key226239998
Report Number3012307300-2021-00277
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 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2021
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? No
Date Returned to Manufacturer12/21/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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