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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1; WARMER, THERMAL, INFUSION FLUID
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ST PAUL LEVEL 1; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number H-1129
Device Problem Electrical Power Problem (2925)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Type  malfunction  
Event Description
It was reported that a smiths medical fluid wramer pulls to much amperage from the putlets and trips the breakers in the shop and the meters in the or no adverse patient effects were reported.
 
Manufacturer Narrative
Additional information- added to event information in section b5.
 
Event Description
No patient involvement.
 
Manufacturer Narrative
Other, other text: device evaluation: one level 1 normoflo irrigation fast flow system was returned for analysis.Visual inspection performed, and device found with regulator box damages.Visual inspection and testing of all components with multimeter, could not find damages components and all components passed electrical testing.Investigation could not duplicated customer reported reason.Investigator replaced device line cord, main pcb, actuator pole, actuator membrane switch, aux outlet, and rolling base compressor, power supply as preventative action.
 
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Brand Name
LEVEL 1
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10552516
MDR Text Key207492428
Report Number3012307300-2020-09481
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085812904
UDI-Public50695085812904
Combination Product (y/n)N
PMA/PMN Number
K072080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH-1129
Device Catalogue NumberH-1129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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