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

Model Number 5000

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2020

Event Type  malfunction  

Event Description

Information was received indicating that the filter to a smiths medical level 1 equator convective warming device was found to have severe thermal deformation.It was reported that the cause of the filter damage was from thermal heating or possible fire.There were no reported adverse effects.

Manufacturer Narrative

Additional information was received from the customer that the fault occurred while in use with a patient.There were no reported adverse patient effects.

Manufacturer Narrative

Evaluation results: one level 1 equator blower was returned for investigation in used condition.Visual inspection revealed that the unit had severe burn damage.The plastic part of the filter had melted. the heater and chassis were also badly burned.The investigator subsequently powered the device on and noted that the motor failed to run.The unit had failed to heat.The customer reported product problem (heat damage) was confirmed during testing.The product problem occurred because the heater had shorted 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.The problem source of the reported product problem was unknown.A root cause was not established.The unit was determined to be beyond economical repair due its old age and condition.No repairs were made.

• Brand Name: LEVEL 1 EQUATOR CONVECTIVE WARMING DEVICE
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 10017000
• MDR Text Key: 189577906
• Report Number: 3012307300-2020-03579
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5000
• Device Catalogue Number: EQ-5000-DE-230V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability