LEVEL 1? HOTLINE? BLOOD AND FLUID WARMER HL-90 CON-HL-90

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for LEVEL 1? HOTLINE? BLOOD AND FLUID WARMER HL-90 CON-HL-90 manufactured by Smiths Medical Asd; Inc..

Event Text Entries

[185901352] One hotline? Blood and fluid warmer was returned for analysis. The enclosure, front cover, and line cord were observed to be damaged upon visual inspection. The unit was functional tested by filling the tank with water, attached the temp check, plugged in line cord, and turned on power switch; no power noted. Based on the evidence, the complaint was confirmed. The root cause was found due to a faulty pcb.
Patient Sequence No: 1, Text Type: N, H10


[185901353] Information was received indicating that a smiths medical level 1? Hotline? Blood and fluid warmer would not power on. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02642
MDR Report Key9908305
Report SourceUSER FACILITY
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2019-09-13
Device Manufacturer Date2018-12-27
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS,, MN
Manufacturer CountryUS
Manufacturer Phone3833310
Manufacturer G1SMITHS MEDICAL ASD; INC.
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS,, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEVEL 1? HOTLINE? BLOOD AND FLUID WARMER
Generic NameWARMER, THERMAL, INFUSION FLUID
Product CodeLGZ
Date Received2020-03-31
Returned To Mfg2019-10-01
Model NumberHL-90
Catalog NumberCON-HL-90
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD; INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS,, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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