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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID
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HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problem No Audible Alarm (1019)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation- the device was returned for evaluation.The device was given functional testing.During testing the reported issue (no over temp alarm) was confirmed.The temperature alarm control was out of calibration.The examination of the device's service records showed no previous returns to smiths medical for service.The issue was determined caused by damage during use.
 
Event Description
It was reported the over temp alarm did not work.No adverse effects reported.
 
Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.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.
 
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Brand Name
HOTLINE FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
MDR Report Key10953716
MDR Text Key219886094
Report Number3012307300-2020-12164
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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