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

Model Number HL-90

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the warmer display is not working.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.

Manufacturer Narrative

Date of event and udi number is unknown.No information has been provided to date.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.Health impact and evaluation codes: updated one device was returned for investigation with a cracked enclosure and a damaged line cord.Filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.Performed functional tests.The liquid crystal display (lcd) was damaged and not working confirming the customer complaint.Root cause of the issue was found to be due to impact damage.A device history record (dhr) review was not done as the device is more than a year beyond the manufacturing date.A service history review showed that the device had not been in for service in the previous year.No action was taken due to the device being beyond economical repair.

• 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; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16542011
• MDR Text Key: 311292021
• Report Number: 3012307300-2023-02440
• Device Sequence Number: 1
• Product Code: LGZ
• 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,Followup
• Report Date: 05/03/2023

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-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1