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

Model Number HL-390

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the main board is broken.Patient involvement unknown.

Manufacturer Narrative

Other text: b3: date of event is unknown.Device evaluation: one device was received for investigation.The front cover was removed for a visual inspection and a broken led was found on the motherboard.The functional test showed that one of the led's was broken off which confirmed the customer complaint.The root cause was found to be user damage.The pcb was replaced.A manufacturing dhr review was not performed because the device is beyond a year from its manufacture date of 2017-02-21 and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• 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: 17129982
• MDR Text Key: 317186820
• Report Number: 3012307300-2023-06243
• 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: Other
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• 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: HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1