MAUDE Adverse Event Report: ST PAUL LEVEL 1 EQUATOR BLOWERS; WARMER, THERMAL, INFUSION, FLUID

Catalog Number CON-EQ-5000

Device Problems Mechanical Problem (1384); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.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evaluation.Visual and functional testing were performed.Wear and tear damage observed to top and bottom enclosure.An outdated membrane switch.The technician started with a visual inspection then attached test hose, plugged in line cord, pressed the on button, and selected high on the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 device heated to the highest temperature selected and didn't go any higher.The reported issue was not duplicated.The root cause of the reported issue could not be confirm.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.

Event Description

It was reported that the customer wanted to replace 4 old units with the new ones.The customer mentioned it was because the current units were overheating (going above the max heat setting) and that the cords needed to be wiggled sometimes for the units to work.No patient injury or involvement was reported.

• Brand Name: LEVEL 1 EQUATOR BLOWERS
• Type of Device: WARMER, THERMAL, INFUSION, FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16787196
• MDR Text Key: 313828337
• Report Number: 3012307300-2023-04364
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CON-EQ-5000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1