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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE 390 FLUID WARMING DEVICE; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE 390 FLUID WARMING DEVICE; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-390
Device Problem Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported the device was not calibrating.No patient involved.
 
Event Description
Additional information received 22 december: the device was in use with patient and was removed from use.No patient injury reported.
 
Manufacturer Narrative
Other text: additional information- the device was in use with patient and was removed from use.No patient injury reported.Device evaluation- the device was returned for evaluation.The device was given functional testing and the investigator could not calibrate the output temperature.The reported issue was determined caused by a faulty electronic assembly board.The cause of the component failure was not definitely established.
 
Manufacturer Narrative
Other text: additional information- the device was in use with patient and was removed from use.No patient injury reported.Device evaluation- the device was returned for evaluation.The device was given functional testing and the investigator could not calibrate the output temperature.The reported issue was determined caused by a faulty electronic assembly board.The cause of the component failure was not definitely established.
 
Event Description
Additional information received (b)(6): the device was in use with patient and was removed from use.No patient injury reported.
 
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Brand Name
LEVEL 1 HOTLINE 390 FLUID WARMING DEVICE
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
NULL
3350 granada ave n
oakdale MN 55128
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, MN 55442
7633833310
MDR Report Key13068942
MDR Text Key285192591
Report Number3012307300-2021-13095
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 01/25/2022
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 Manufacturer12/21/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/24/2021
Initial Date FDA Received12/22/2021
Supplement Dates Manufacturer Received12/22/2021
12/22/2021
Supplement Dates FDA Received01/25/2022
01/25/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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