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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL LEVEL 1 FLUID WARMER; WARMER, THERMAL, INFUSION FLUID
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NULL LEVEL 1 FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Device Problem Failure to Sense (1559)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Returned device was received in worn physical condition.There was wear and tear damage to the enclosure, front cover and water tank cover.During the evaluation of the device, the reported issue was able to be replicated by analysts.It was determined to be a faulty float 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.
 
Event Description
Information was received indicating that a smiths medical fluid warmer was reading low fluid even when full.There were no reported adverse events.
 
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Brand Name
LEVEL 1 FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section G)
NULL
MDR Report Key11589079
MDR Text Key242931136
Report Number3012307300-2021-02645
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 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2006
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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