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

Model Number HL-390

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the warmer display is blank.No report of patient involvement.

Manufacturer Narrative

Date of event is unknown, no information has been provided to date.A product sample was received and is awaiting evaluation, 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, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was returned for investigation.It was noted that the entire device has multiple scuff marks, and the liquid crystal display (lcd) had liquid crystal leakage and the water tank leaked when filled with water, chassis was missing a screw and corroded quick drain connect.Put water in tank, attached temperature check, plugged line cord into outlet, turned device on, brought circulating water up to 42.0 degrees.Functional testing confirmed the customer complaint.A root cause was determined to be due to the device being dropped or sharply impacted.A manufacturing device history review was not performed as the device is a year past the manufacturing date.Service history review identified this device has not been in for service previously.Replaced the printed circuit board (pcb), front cover, water tank cover, quick connected and performed preventative maintenance (pm).Device passed all functional tests.

• 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: 16685631
• MDR Text Key: 312733182
• Report Number: 3012307300-2023-03576
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

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-390
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1