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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL LEVEL 1 FLUID WARMER; SET, ADMINISTRATION, INTRAVASCULAR
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NULL LEVEL 1 FLUID WARMER; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Returned device was received in poor physical condition.There was wear and tear to the enclosure, front cover, water tank cover, drain fitting, reflux plug 390, and line cord.During the evaluation of the device, the pcb display/screen was damaged.The reported issue was replicated.The pcb was replaced to resolve the issue.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's display is not showing the correct temperature and the device goes out after a short run.There were no reported adverse events.
 
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Brand Name
LEVEL 1 FLUID WARMER
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key11187116
MDR Text Key227547709
Report Number3012307300-2021-00551
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 Other
Type of Report Initial
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
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 Manufacturer01/07/2021
Was the Report Sent to FDA? No
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2018
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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