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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; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problem Unable to Obtain Readings (1516)
Patient Problem Insufficient Information (4580)
Event Date 12/01/2023
Event Type  malfunction  
Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.H3 - other: device has not been returned to date.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.
 
Event Description
It was reported that the warmer fluid level indicator is broken.Patient involvement is unknown.
 
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Brand Name
LEVEL 1 HOTLINE 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 Key18511220
MDR Text Key333503064
Report Number2183161-2024-00049
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public(01)50695085820909(11)150113(12)S101A02988
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 Biomedical Engineer
Type of Report Initial
Report Date 01/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberHL-90
Device Catalogue NumberCON-HL-90
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2015
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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