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

Model Number 1200

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

Information received by a customer smiths medical fluid warming|level 1 trauma fast flow systems - h-1200 is having a sensor issue with number 2 position on the h1200.

• Brand Name: LEVEL ONE
• Type of Device: FLUID WARMING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 12343182
• MDR Text Key: 267294276
• Report Number: 3012307300-2021-08614
• 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: 08/19/2021

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
• Device Model Number: 1200
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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