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

Catalog Number CON-HL-90

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

It was reported that the lcd is malfunctioning.No additional information.

Event Description

It was reported that the lcd is malfunctioning.No additional information.

Manufacturer Narrative

Additional information: d3, d5, e4 and g2 this mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.The device history report ( dhr) review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.A product sample was received for evaluation.Visual and functional testing were performed.Blank liquid crystal display (lcd).Wear and tear damaged enclosure, tank cover, and plate clip.Faded line cord and dirty heater.Started with a visual inspection then filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.The device was powered on and the lcd was blank confirming the customer complaint.The root se cause of the reported issue was found to be faulty printed circuit board (pcb).Replaced the pcb., corrected data: corrected information : h3 and h6.

Event Description

Additional information received an email on 09-nov-2022.Event occurred during preventive maintenance.No patient injury was reported.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• 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: jim vegel ; 6000 nathan lane north; dock 5; minneapolis, MN 55442
• MDR Report Key: 13537390
• MDR Text Key: 285703278
• Report Number: 3012307300-2022-03433
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1