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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 Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Returned device was received in poor physical condition but there was wear and tear damage to the enclosure, front cover, drain fitting and line cord.During the evaluation of the device, the issue was able to be replicated.There was leaking from the water tank cover.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 had a damaged reservoir cover and it was leaking water.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 Key11921470
MDR Text Key253773824
Report Number3012307300-2021-05391
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 06/02/2021
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/04/2021
Initial Date FDA Received06/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2019
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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