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

Model Number HL-90

Device Problem Device Fell (4014)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that a smiths medical fluid warmer was dropped/ broken parts.No adverse patient effects were reported.

Manufacturer Narrative

One fluid warmer was received for evaluation.Visual inspection of the device found it to have a cracked tank cover, the display broken off pcb and hanging out front cover, and outdated pcb, power switch, and front cover.The reported customer complaint was confirmed through visual inspection; no action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.The problem source has been determined to be user interface, as the device had been dropped.

• Brand Name: LEVEL 1 LOW FLOW FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10558446
• MDR Text Key: 207691095
• Report Number: 3012307300-2020-09603
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1