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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-390
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2023
Event Type  malfunction  
Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.Device evaluation: one device was received with front cover and enclosure having multiple nicks and scratches, line cord faded and worn, microswitch missing lever arm, printed circuit board (pcb) missing light emitting diode (led), water tank cover had cracks in the corners, quick connect corroded.The complaint was verified by visually observing there was no lever arm on the microswitch.The most probable cause would be the customer forcing a disposable into the microswitch.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 micro switch was bad and not recognizing set.It was unknown when the event occurred.No patient or clinical injury was reported.
 
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Brand Name
LEVEL 1 HOTLINE FLUID WARMER, 390
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 Key18512736
MDR Text Key333355016
Report Number2183161-2024-00055
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier10695085002796
UDI-Public10695085002796
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 Other Health Care Professional
Type of Report Initial
Report Date 01/15/2024
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 Health Professional
Device Model NumberHL-390
Device Catalogue NumberCON-HL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2023
Initial Date FDA Received01/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2019
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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