MAUDE Adverse Event Report: NULL LEVEL 1 FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Device Problem Electrical Power Problem (2925)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Returned device was received in worn physical condition.During the evaluation of the device, the issue was able to be confirmed and it was found to be isolated to the faulty line cord.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.

Event Description

Information was received indicating that a smiths medical fluid warmer was not able to get resistant for continuity.There were no reported adverse events.

• Brand Name: LEVEL 1 FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section G): NULL
• MDR Report Key: 11931432
• MDR Text Key: 254076968
• Report Number: 3012307300-2021-05455
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2014
• 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