SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS 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 2020-02-14 for SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS CON-HL-90 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[179721149] Information was received that a smiths medical level 1 hotline low flow system had a slow leak. No adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-01120
MDR Report Key9714512
Report SourceUSER FACILITY
Date Received2020-02-14
Date of Report2020-03-13
Date Mfgr Received2020-02-19
Device Manufacturer Date2007-01-17
Date Added to Maude2020-02-14
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 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 NameSMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS
Generic NameWARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Product CodeBSB
Date Received2020-02-14
Catalog NumberCON-HL-90
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-14

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