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

Model Number HL-90

Device Problems Break (1069); Display Difficult to Read (1181)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Udi section is unknown, no product information has been provided to date.Date of event and operator of device is unknown.The device was received with a cracked enclosure and tank cover, an outdated pcb (printed circuit board) and power switch.No previous repairs were noted.The device had impact damage to the lcd (liquid crystal display) which resulted in liquid crystal leakage.A manufacturing dhr (device history record) review was not performed because the device is beyond a year from its manufacture date of 1998 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.

Event Description

It was reported that the warmer lcd (liquid crystal display) was damaged.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

• 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): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 677 church st; minneapolis, MN 55442
• MDR Report Key: 16362326
• MDR Text Key: 309410623
• Report Number: 3012307300-2023-01165
• 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
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1