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

Catalog Number CON-HL-90

Device Problem Failure to Calibrate (2440)

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

Event Type  malfunction  

Manufacturer Narrative

Udi information is unknown.Initial reporter also sent report to fda is unknown.No information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No device history review (dhr) is not applicable or relevant due to the device manufactured date.The investigation did not implicate a service process issue.A product sample was received for evaluation.Functional and visual testing were performed.The device was received in used condition.The evaluation was performed, and the reported issue was confirmed.A liquid crystal display (lcd) was noted to be leaking at the bottom edge.Installed test tool and powered on unit.Removed front cover and investigated further.Found circuit board lcd display was inaccurate.The seal was broken on potentiometers indicating they had been turned after being originally set by manufacturing.Lcd could not be adjusted as potentiometer was found not functional.Reported issue due to damaged circuit board.The root cause of the reported issue was due normal wear and tear.Device was over 19 years old.No further actions are required.

Event Description

It was reported that the device can't calibrate.No patient injury was reported.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15642243
• MDR Text Key: 306683653
• Report Number: 3012307300-2022-25522
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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
• Date Returned to Manufacturer: 11/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1