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

Catalog Number EQ-5000-FR-230V

Device Problem Temperature Problem (3022)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  malfunction  

Event Description

It was reported that the vice was blowing too hot air causing redness on the patient's legs.No medical or surgical intervention was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual and functional testing were performed.No physical damages were observed.Sample was powered on and tested with multiple temperature settings but the temperature was in range the whole time.The temperature remains stable and in the range.The root cause of the reported issue was not able to be determined.Actions were taken to mitigate the reported issue: replace the filter, replace the power cord clip.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.D4: udi information is unknown.G5: premarket (510k) number is unknown.E4: initial reporter also sent report to fda is unknown.Operator of device is unknown.

• Brand Name: LEVEL 1 EQUATOR BLOWERS CONVECTIVE WARMING
• 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: 16909106
• MDR Text Key: 314975688
• Report Number: 3012307300-2023-05527
• Device Sequence Number: 1
• Product Code: LGZ
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: EQ-5000-FR-230V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female