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

Model Number HL-90

Device Problems Failure to Sense (1559); Key or Button Unresponsive/not Working (4063)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: date of event is unknown, no information has been provided to date.G5: 510k is blank, this catalog number is not sold in the united states.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.

Event Description

It was reported that the tube sensing switch was not working.Patient involvement is unknown.

Manufacturer Narrative

Other, other text: g2 email is: regulatory.Responses@icumed.Com.Device evaluation: one device was returned for investigation.Visual inspection found the device has cracks on the water tank enclosure and was received with the front enclosure partially deattached.Reflux plug is missing.Functional testing found the device failed the microswitch test.The complaint was confirmed.Root cause was attributed to the microswitch malfunctioning.What caused this condition could not be established.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.Microswitch, water tank enclosure, o-rings and power cord were replaced.Device passed functional testing after the completed repairs.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 230V 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: 17921113
• MDR Text Key: 325586827
• Report Number: 3012307300-2023-09627
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• 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?: No
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1