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

Catalog Number CON-EQ-5000HF-115V

Device Problem Excessive Heating (4030)

Patient Problems Burn(s) (1757); Blister (4537)

Event Date 09/01/2021

Event Type  Injury  

Event Description

It was reported that the convective warming unit was being used with an upper body warming blanket.Machine was turned on to warm at 44 degrees celsius to maintain body temp.Upon completion of the case the blanket was removed and clinicians discovered "multiple fluid filled blisters in a straight line on the inside of the patient's arm", which was the same side that the hose was connected into the blanket to circulate air.Customer said medical intervention was provided and the patient's burn was treated.No surgical intervention was reported.

Manufacturer Narrative

Additional information: udi and pma/510k are unknown.No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The device had a noisy fan.The technician started with a visual inspection then attached test hose, plugged in line cord, pressed the "on" button, and selected high on the keypad.The reported problem was not confirmed.The device ran for several hours with no overheating but very noisy.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.

Manufacturer Narrative

Type of reportable event: serious injury.

• Brand Name: LEVEL 1 EQUATOR BLOWERS
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16600543
• MDR Text Key: 312217218
• Report Number: 3012307300-2023-02960
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CON-EQ-5000HF-115V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention