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

Model Number HL-90

Device Problems No Display/Image (1183); Fluid/Blood Leak (1250); Excessive Heating (4030)

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

Event Type  malfunction  

Event Description

It was reported the device had a broken led screen, overheating issues and leaking.Reporter could not confirm whether any patient was involved.No adverse effects reported.

Manufacturer Narrative

Other text: additional: d4 udi is unknown.No product information has been provided to date.H6 this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No manufacturing or service issues were identified as causes of the customer's reported problem 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testing were performed.Wear and tear damaged enclosure, front cover, and cracked tank cover.The device had an outdated printed circuit board (pcb) and power switch.Started with a visual inspection then filled tank with water, attached temperature check, plugged in line cord,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 reported issue was found to be an impact to the front of the device that broke the light-emitting diode (led).Wear and tear of daily use caused damage to the connection between the power switch and pcb, which was caused by the user.The device will be scrapped.,.

Event Description

Additional information via email 18-nov-2021.Event date unknown and patient involvement unknown.

• 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: 12911153
• MDR Text Key: 281534278
• Report Number: 3012307300-2021-11961
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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-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: 02/02/2023
• 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