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

Model Number HL-90

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the warmer was overheating.No patient injury was reported.

Manufacturer Narrative

B3: date of event and d4: 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 text: d10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received with scratches on the front cover, a small crack on the upper part of the water tank cover, line cord was faded, printed circuit board (pcb) stand offs were not attached to the liquid crystal display (lcd).The complaint was confirmed during functional testing.A root cause was due to the device overheating from a faulty water pump not recirculating water however it is unknown what caused the fault.A device history record (dhr) review was not performed because the device is beyond a year from its manufacture date 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.Replaced pump, pcb, water tank cover, line cord, rusty dual thermistor, microswitch, and front cover.Performed preventative maintenance (pm) and calibrated.Device passed all functional and delivery 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: 16728204
• MDR Text Key: 313651174
• Report Number: 3012307300-2023-04049
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• 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: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1