MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, MODEL 390; WARMER, THERMAL, INFUSION FLUID

Catalog Number CON-HL-390

Device Problem Failure to Calibrate (2440)

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

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Udi information is unknown.A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Damaged line cord and bent micro switch.Filled tank with water, attached temp check, plugged in line cord, and turned on power.Couldn't make any adjustments on power control board.The root cause of the reported issue was found to be a faulty power control board.Actions were taken to mitigate the reported issue: replaced the power control board.

Event Description

It was reported that the device was unable to calibrated.No patient injury was reported.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, MODEL 390
• 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: 15653391
• MDR Text Key: 306695077
• Report Number: 3012307300-2022-25788
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1