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

Model Number EQ-5000

Device Problem Temperature Problem (3022)

Patient Problems Partial thickness (Second Degree) Burn (2694); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  Injury  

Event Description

It was reported the device was in use with patient during surgery (laparoscopic prostatectomy) with the device temperature setting of 44 degrees c.The patient showed swelling at the chest, neck and arms: the day after surgery blisters appeared (second degree burn).No intervention was determined necessary.According to reporter, "no signs of thermal injury were noted during the operation, but inspection was limited due to patient positioning, surgical drapes, and the warming blanket itself." no adverse effects reported.

Manufacturer Narrative

Other, other text: additional information received on jun 1rst attached photos of left upper arm with second degree burns blisters.The left side of chest has red marks.Complaint revealed no sheet between the blanket warming and patient, as just a hospital gown was the barrier between the warming blanket.No visual alarm occurred to alert over temperature.The facility reported the presentation of wound is clearly a burn mark that occurred during an operation that lasted over three hours.No prep or adhesive to the area of skin was used.

Event Description

Additional information summary in h 10.

Event Description

Additional information summary in h 10.

Manufacturer Narrative

Other, other text: additional information received on jun 1st attached photos of left upper arm with second degree burns blisters.The left side of chest has red marks.Complaint revealed no sheet between the blanket warming and patient, as just a hospital gown was the barrier between the warming blanket.No visual alarm occurred to alert over temperature.The facility reported the presentation of wound is clearly a burn mark that occurred during an operation that lasted over three hours.No prep or adhesive to the area of skin was used.

Manufacturer Narrative

Correction- file is duplicate of 3012307300-2021-01757.No further reports will be filed under file number 3012307300-2021-04355.

• Brand Name: LEVEL 1 EQUATOR CONVECTIVE WARMER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11825716
• MDR Text Key: 250643662
• Report Number: 3012307300-2021-04355
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: 50695085850005
• Combination Product (y/n): N
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EQ-5000
• Device Catalogue Number: CON-EQ-5000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1