MAUDE Adverse Event Report: ST PAUL LEVEL ONE; FLUID WARMER

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths medical fluid warming|level 1 hotline low flow systems - hl-390.The complaint of faulty switch was confirmed with powering device on.The physical condition of device revealed wear and tear damage to drain fitting, enclosure, water tank cover, front cover, pole clamp, and line cord.No action was taken to repair device due to age and condition.The device was scrapped.

Event Description

Ro (b)(4): malfunctioning membrane switch.

• Brand Name: LEVEL ONE
• Type of Device: FLUID WARMER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 12380251
• MDR Text Key: 268563864
• Report Number: 3012307300-2021-08926
• 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
• Report Date: 08/27/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/3021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1