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

Model Number HL-390

Device Problems Failure to Power Up (1476); Power Problem (3010)

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

Event Type  malfunction  

Event Description

It was reported that the fluid warming device had no power.No patient injury was reported.No other information has been provided at this time.

Manufacturer Narrative

Manufacturing device history record 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.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found a cracked enclosure and tank cover, outdated printed circuit board (pcb) and power switch.Functional testing found the device had no power confirming the customer complaint.The root cause of the reported issue was found to be a design issue - the connection between the pcb and power switch had been broken.This was caused by wear and tear use of the power switch.This issue has been escalated to an internal capa and will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.No action taken due to the age and condition of the device.It was deemed beyond economical repair and will be scrapped.D5 and e4 are unknown, no information provided to date.

• 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: 14516447
• MDR Text Key: 293104995
• Report Number: 3012307300-2022-09726
• 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,Followup
• Report Date: 09/06/2022

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 Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1