MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 230 V UK MODEL; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problems Circuit Failure (1089); Failure to Power Up (1476)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

D4: udi section is unavailable, g5: 510k is blank, catalog number is not sold in the us.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported that during pre-testing, the unit was not turning on.The customer noted that the "fuse was blown".No adverse patient effects were reported by the customer.

Manufacturer Narrative

Device evaluation: one warmer device was received for investigation.During visual inspection the device was observed to be in good condition.The reported issue was confirmed during functional testing when the device was powered on and a fuse was expended.The issue was traced to the device power cord, which was determined to be defective.As no manufacturing root cause could be identified, no review of manufacturing device history records was conducted.The power cord was replaced and the device passed all electrical safety tests, but no root cause could be attributed for its observed condition.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 230 V UK MODEL
• 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: 16864122
• MDR Text Key: 314554650
• Report Number: 3012307300-2023-05003
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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: HL-90-UK-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1