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

Catalog Number CON-HL-90

Device Problem Failure of Device to Self-Test (2937)

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

Event Type  malfunction  

Manufacturer Narrative

One device was returned for investigation.The returned sample was visually inspected, and the device was noted to have a cracked tank cover and an outdated printed circuit board (pcb) and power switch were noted.The investigator started with a visual inspection then filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.Then ran on the safety/electrical test which it failed.To use the test to help diagnose the problem the main components are unplugged from the pcb one by one, and the test is run again each time a component is removed.The customer's complaint was confirmed, the device failed the safety/electrical test.In this case it was the heater that caused the failure.They were unable to determine the cause of the failure.No action taken due to the age and condition of the device.It was deemed beyond economical repair and will be scrapped.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.

Event Description

It was reported that the fluid warming device failed an electrical safety test.No patient injury was reported.No other information has been provided at this time.

• 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: 14496625
• MDR Text Key: 292806462
• Report Number: 3012307300-2022-09615
• 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
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• 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: 05/03/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1