MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS; WARMER, THERMAL, INFUSION FLUID

Model Number	H-1100 SERIES
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that this smiths medical level 1 normoflo irrigation fast flow systems pole did not go down and the device had corroded board.No reported adverse effects.
Additional Manufacturer Narrative
Other, other text: returned device was received in poor condition with physical damage.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10396744
• Report Number: 3012307300-2020-08099
• Device Sequence Number: 14107975
• Product Code: LGZ
• UDI-Device Identifier: 50695085828264
• UDI-Public: 50695085828264
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/12/2020

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-1100 SERIES
• Device Catalogue Number: H1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1