MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 CONVECTIVE WARMER; SYSTEM, THERMAL REGULATING

Model Number L1-CW-220V

Device Problem Fire (1245)

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

Event Type  malfunction  

Manufacturer Narrative

One thermal regulation device was received for evaluation in relation to the reported event.It was noted that the device was in good condition externally with no outer indications of the reported event.A review of the event history log noted entries that may be related to the reported event, including the codes error, error,21: thermal cutout and error, error, 7: button stuck.Functional testing of the device was unable to be completed as the device was found to be inoperable.The device was opened which then revealed evidence of fire/heat damage, as a part from the ac distribution board was melted.After further investigation it was discovered that multiple internal components were damaged by the fire/heat.The reported event was confirmed.The cause was determined to be a defective ac distribution board, which was replaced to resolve the issue.All of the other damaged internal components as a result of the fire/heat damage were also replaced.A corrective action has been initiated with the supplier, and this is a known design issue being corrected by the supplier.A manufacturing 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.

Event Description

It was found that when the device was received for normal service at the servicing facility.That the device was completely inoperable.After the device was opened on the ac distribution board burn marks were presented and the bottom enclosure together with the exit muffler were a little bit carbonized, signaled that a fire was inside.There was no patient involvement reported.

Manufacturer Narrative

Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Additional information: updated d4 (catalog number), g5, h6., corrected data: b1 - product problem, d1, h5.

• Brand Name: LEVEL 1 CONVECTIVE WARMER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13479813
• MDR Text Key: 285225075
• Report Number: 3012307300-2022-02864
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K181699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L1-CW-220V
• Device Catalogue Number: L1-CW-220V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1