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

Catalog Number CON-HL-90

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Event Description

It was reported that there was no display.

Manufacturer Narrative

Correction- g1 updated.Device evaluation- the device was returned for evaluation.The device was powered on for functional testing; this showed the lcd screen displayed incomplete numbers.The issue was determined caused by a problem with the printed circuit board.The cause of the component was not established.

Manufacturer Narrative

Additional d1 d3 d4 catalog number g5 d4 udi is unknown.No product information has been provided to date.This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Received device in multiple components damaged.Started with a visual inspection then filled tank with water, attached temperature check, plugged in line cord, and turned on the power switch.The reported issue was confirmed.The no pixels on the liquid crystal display when device was on.The root cause of the reported issue was found to be faulty board.The technician replaced the faulty board.No problems or issues were identified during the device history record review., corrected data: corrected d10 g1 h3 and h6.

• 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; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 12344592
• MDR Text Key: 267338889
• Report Number: 3012307300-2021-08620
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1