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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ
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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ Back to Search Results
Catalog Number CON-HL-90
Device Problems Failure to Power Up (1476); Power Problem (3010); Complete Loss of Power (4015)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received that a smiths medical level 1 hotline blood and fluid warmer was not powering on.No adverse patient effects were reported.
 
Manufacturer Narrative
Device evaluation: returned device was received front cover is dirty and scuffed.Water tank cover is cracked.Drain fitting is rusted.Pole clamp is dirty and damaged.Missing reflux plug.Pcb board and power switch is outdated.During the evaluation of the device a broken power switch was found.The customer reported condition was confirmed.Problem source is unknown.The device history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
LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key9715271
MDR Text Key179718294
Report Number3012307300-2020-01115
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 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2020
Date Manufacturer Received03/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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