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

Model Number HL-90

Device Problems Device Alarm System (1012); Display or Visual Feedback Problem (1184)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the over temperature alarm and "lad" was not working.Patient involvement unknown.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other text: d10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received dirty, front cover broken, water tank cracked, float switch was stained, microswitch had broken lever, serial number and "tuv" were torn.Functional testing confirmed the complaint as the device failed on water level; when depressing the float switch the unit did not alarm, and led did not light.The root cause was due to a faulty printed circuit board (pcb).It was unknown what caused the fault.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Replaced printed circuit board (pcb), float switch, water tank cover, microswitch, line cord, front cover.Performed preventative maintenance (pm) and calibrated.Device passed all functional and delivery tests.

Event Description

Additional information was received confirming the issue with this device was discovered during a routine preventive maintenance procedure.No known patient involvement.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16890890
• MDR Text Key: 314780521
• Report Number: 3012307300-2023-05341
• 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,Followup,Followup
• Report Date: 09/27/2023

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 08/29/2023; 09/05/2023
• Supplement Dates FDA Received: 08/30/2023; 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1