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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received indicating that a smiths medical level 1® equator® convective warming device burned a patient.There were no reported further adverse effects.

Manufacturer Narrative

The file was inadvertently marked reportable.The event reported under mfr 3012307300-2019-03211 was determined to be not reportable as it was found to be a duplicate complaint and no further reports will be filed using this file number.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.

• 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 55442
• MDR Report Key: 8689387
• MDR Text Key: 147733275
• Report Number: 3012307300-2019-03211
• 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
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1