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

Model Number HL-90

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation- the device was returned for evaluation.The device was powered on and the display showed liquid crystal leakage.The cause of the component failure was not definitely established.

Event Description

It was reported the device display could not be read.Issue was found during preventive maintenance; no patient involved.

Manufacturer Narrative

Additional information b5 d5 h6.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.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Wear and tear damaged enclosure and front cover.Cracked tank cover.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 problem was confirmed.There was liquid crystal leakage in the liquid crystal display.The root cause of reported issue is dropping of the device by customer.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped., corrected data: d2 g1 g5.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMING DEVICE
• 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; main receiving dock; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 12808267
• MDR Text Key: 280763054
• Report Number: 3012307300-2021-10635
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2021
• 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-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• 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