MAUDE Adverse Event Report: ST PAUL LEVEL 1; WARMER, THERMAL, INFUSION FLUID

Model Number	H-1129
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Additional information- added to event information in section b5.
Event or Problem Description
No patient involvement.
Additional 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.

• Brand Name: LEVEL 1
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10552516
• Report Number: 3012307300-2020-09481
• Device Sequence Number: 2803274
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: 50695085812904
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K072080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: H-1129
• Device Catalogue Number: H-1129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/29/2020; 11/18/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/28/2020; 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1