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

Catalog Number CON-HL-390

Device Problem Mechanical Problem (1384)

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).D4: 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.Received device in fair condition.The unit failed to power on.Removed front cover and investigated further.There was burning odor.Power switch connector was found broken.There was evidence of black char at the back of the circuit board.This could be the reason for the burning odor.The root cause of the reported issue was found to be an electrical short caused by breaking solder joint between power switch.Actions were taken to mitigate the reported issue: are unknown.A corrective and preventative action has been opened to address the reported issue.

Event Description

It was reported that the warmer had a bad power switch.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; 123 international way access a; minneapolis, MN 55442
• MDR Report Key: 15639715
• MDR Text Key: 306889519
• Report Number: 3012307300-2022-25412
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1