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

Model Number EQ-5000

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 02/08/2024

Event Type  Injury  

Event Description

It was reported that in order to maintain the patient's body temperature during the operation, the convective warming machine was initially kept at 36°c.However, due to subsequent extensive flushing, the patient's body temperature dropped, so it was adjusted to 40°c.The device was not connected as required (but a cloth was wrapped around the hot air outlet).The sensor at the air outlet fell off during use, causing a real-time temperature control failure and the device remained continuously heating.Due to the long duration of the operation, the patient suffered burns over a large area from the back of the right shoulder to the right upper arm, and there were blisters in some areas.Later, engineers from the hospital put the equipment into test, it was found that if the temperature probe is detached and the temperature is set to 44°c (during test), the equipment will continue to heat, but the temperature will remain at about 53°c, and this could cause burns to the patient.

Manufacturer Narrative

H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: LEVEL 1 CONVECTIVE WARMER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18954054
• MDR Text Key: 338306432
• Report Number: 3012307300-2024-01567
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQ-5000
• Device Catalogue Number: EQ-5000-CN-230V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female