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

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Returned device was received in poor physical condition.There was wear and tear to the drain fitting, enclosure, water tank cover, front cover, and line cord.During the evaluation of the device, the microswitch was confirmed to be faulty.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 had a suspected faulty micro switch.There was no injury reported and no reported adverse events.

Manufacturer Narrative

One device received for investigation with wear and tear to drain fitting, enclosure, water tank cover, front cover, and line cord.Function resting performed and based on the evidence the reported issue was duplicated.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.The root cause was unable to be determined.

• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section G): NULL
• MDR Report Key: 12020482
• MDR Text Key: 257473397
• Report Number: 3012307300-2021-06207
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2001
• 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