MAUDE Adverse Event Report: ST PAUL LEVEL 1; WARMING DEVICE.

Model Number HL-390

Device Problems Break (1069); Failure to Power Up (1476); Device Fell (4014)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information received a smiths medical fluid warming|level 1 hotline low flow systems - hl-390 was dropped and as a result the front case/ leds are broken and not powering on.No adverse patient events reported.

Manufacturer Narrative

Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.Visual inspection revealed that the pcb was broken, the enclosure was cracked at the water tank cover and front cover, both covers were cracked, and the line cord was worn.The investigator subsequently filled the tank with water, plugged in the line cord, attached a temperature check fixture, and turned on the power switch.The customer reported product problem (broken led/failure to power on) was confirmed during testing.The product problem occurred because the unit was dropped.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.A user issue (dropped unit) was identified as the root cause of the product problem.The pcb was replaced.Preventative maintenance was then performed.The device subsequently passed functional testing.

• Brand Name: LEVEL 1
• Type of Device: WARMING DEVICE.
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10548847
• MDR Text Key: 207391256
• Report Number: 3012307300-2020-09454
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• Combination Product (y/n): N
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-390
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1