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

Model Number HL-390

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Event Description

It was reported the device lcd was not working.No patient was involved.

Manufacturer Narrative

Other, other text: the failure resulted from physical damage sustained by the device during use and handling.The device history record (dhr) review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found a noisy pump, damaged printed circuit board (pcb), dirty enclosure, cracked tank cover, rusty heater, bent micro switch, broken front cover, and a faded line cord.Functional testing found the display was blank after powering on.The root cause of the reported issue was found to be customer damage to the lcd and printed circuit board (pcb) from impact during use and handling.Replaced the front cover, line cord, micro switch, heater, tank cover, enclosure, printed circuit board (pcb), and pump.The device passed all functional testing.

Event Description

Additional information was received which included that the event date was unknown and there was no patient involvement.

• Brand Name: LEVEL 1 HOTLINE 390 FLUID WARMING DEVICE
• 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 ; 7633833310
• MDR Report Key: 13101435
• MDR Text Key: 282899921
• Report Number: 3012307300-2021-13364
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• 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,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2022
• 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