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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 Noise, Audible (3273)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
One fluid warmer was received for evaluation.Visual inspection of the device found it to have a cracked tank cover.A dhr review was performed subsequent to the manufacturing of the device and prior to its release; no problems or issues were identified during this dhr review.Device tank was filled with water, and powered on-confirming the reported customer complaint.Upon further inspection it was found that the device's pump was very loud as it pumped water.This was due to a faulty pump, and the problem source has been determined to be unknown.
 
Event Description
Information was received that device is noisy and sucking in too much air.No adverse effects reported.
 
Manufacturer Narrative
A1, h6: additional information; incident occurred during testing, no alarms, no patient involvement.
 
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Brand Name
LEVEL 1
Type of Device
HOTLINE LOW FLOW SYSTEM
MDR Report Key10385822
MDR Text Key202231152
Report Number3012307300-2020-08007
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 08/25/2020
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? No
Date Returned to Manufacturer07/21/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/13/2020
Initial Date FDA Received08/10/2020
Supplement Dates Manufacturer Received07/29/2020
Supplement Dates FDA Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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