MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC LEVEL 1 HOTLINE LOW FLOW SYSTEM; WARMER, THERMAL, INFUSION FLUID

Model Number	100/189/085
Medical Device Problem Codes	Break (1069); Power Problem (3010)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the unit was found to have no power and a suspected broken switch connection.No patient injury or complications were reported in relation to this event.
Event or Problem Description
It was reported the unit was found to have no power and a suspected broken switch connection.No patient injury or complications were reported in relation to this event.Additional information was received on 09 march 2020.The product problem was observed during testing.The unit did not provide an alarm because it was not turning on at all.There was no patient involvement.
Additional Manufacturer Narrative
Date recv'd by mfr: 03/09/2020.H6: patient code updated to 2645.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEM
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9753496
• Report Number: 3012307300-2020-01493
• Device Sequence Number: 3308019
• Product Code: LGZ
• UDI-Device Identifier: 15019315059551
• UDI-Public: 15019315059551
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: No Information
• Device Model Number: 100/189/085
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1