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

Model Number HL-90

Device Problems Defective Alarm (1014); Audible Prompt/Feedback Problem (4020)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event and udi #: udi section are unknown, no information has been provided to date.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 device's alarm button sounds but not with the over temperature.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Event Description

Additional information received 9-feb-2023.This occurred during routine preventative maintenance.No patient involvement was reported.

Manufacturer Narrative

D10: device available for evaluation; h3: device evaluated by manufacturer and h6.Event patient, problem and evaluation codes: updated.One (1) device was received, and a visual inspection noted outdated printed circuit board (pcb) and power switch.Filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.The alarms sound when triggered except for the over temp alarm confirming the customer complaint.The over temp alarm was out of calibration and after it was recalibrated, it sounded when it should.A manufacturing device history record (dhr) review was not performed because the device is beyond a year from its manufacture date of 2009 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.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.

• 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: 16308289
• MDR Text Key: 308896150
• Report Number: 3012307300-2023-00921
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• 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: CON-HL-90
• 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: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1