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

Model Number HL-90

Device Problems Failure to Calibrate (2440); Excessive Heating (4030)

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

Event Type  malfunction  

Event Description

It was reported the device could not be calibrated and gave "over temperature" alarm.No patient injury reported.

Manufacturer Narrative

This mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Physical observation revealed cracked and leaking tank cover, damaged printed circuit board (pcb), and faded line cord.Started with a visual inspection then filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.The over temp alarm sounded right away.The membrane switch and all components plugged into the pcb were disconnected.The customer reported problem has been confirmed.The over temp alarm was out of calibration and the pots on the pcb used to calibrate and make adjustments were damaged.The root cause of the reported issue was found to be customer use.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.E4 is unknown.

• 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): NULL; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13447698
• MDR Text Key: 287347931
• Report Number: 3012307300-2022-02518
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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 Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1