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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
Model Number HL-90
Device Problem Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 11/01/2023
Event Type  malfunction  
Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.One device was received.Per visual inspection, cracked tank cover.Damaged light emitting diodes (leds) on printed circuit board (pcb).Outdated pcb and power switch.Per functional testing, the leds were not working confirming the complaint.The root cause was damaged leds.It was unknown what caused the damage.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action taken due to the condition of the device.It was deemed beyond economical repair and was scrapped.
 
Event Description
It was reported that the light emitting diode (led) button was not working properly.Patient involvement unknown.
 
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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 Key18313949
MDR Text Key330940176
Report Number2183161-2023-00007
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public50695085820909
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001764
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 12/12/2023
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
Device Model NumberHL-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2023
Initial Date Manufacturer Received 11/17/2023
Initial Date FDA Received12/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2006
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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