MAUDE Adverse Event Report: ST PAUL LEVEL 1; SYSTEM, THERMAL REGULATING

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

Information was received indicating that a patient using the convective warming leve1 blanket was burned in the forearm.Additional information is being gathered.

• Brand Name: LEVEL 1
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10877355
• MDR Text Key: 217452671
• Report Number: 3012307300-2020-11645
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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