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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
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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number HL-90
Device Problem Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 12/01/2023
Event Type  malfunction  
Event Description
It was reported that the "little flip switch" is no longer engaging properly they've tried to "bend" to get better connection but to no avail.Patient involvement unknown.
 
Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
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Brand Name
LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
3350 granada ave n, suite 100
oakdale MN 55128
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key18457169
MDR Text Key332732081
Report Number2183161-2024-00009
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K911383
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 01/05/2024
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 Other
Device Catalogue NumberHL-90
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2023
Initial Date FDA Received01/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/1995
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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