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

Model Number HL-90

Device Problem Erratic or Intermittent Display (1182)

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

Event Type  malfunction  

Event Description

It was reported the device temperature display showed "random characters".Issue found during maintenance with no patient involved.

Manufacturer Narrative

Other text: additional information: d4: is unknown.No product information has been provided to date.This mdr was generated under protocol b10010116, 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and functional testing were performed.Bent prongs on line cord, cracked tank cover, broken pole clamp, outdated printed circuit board (pcb) and power switch.Started with a visual inspection then filled tank with water, attached temperature check, plugged in line cord,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 not confirmed.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.

Event Description

Additional information received via email 15-nov-2021.Event date unknown.Issue detected during maintenance.No patient involvement.

• 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; receiving; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 12980679
• MDR Text Key: 282101159
• Report Number: 3012307300-2021-12624
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• 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
• Date Returned to Manufacturer: 12/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• 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