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

Catalog Number CON-HL-90

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Event Description

It was reported that there was an error code.No additional information.

Manufacturer Narrative

Other, other text: no device was received for investigation.If the product is returned, smiths medical will reopen this complaint for further investigation.

Manufacturer Narrative

Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).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and functional testing were performed.Physical observation found broken front cover, cracked tank cover, outdated printed circuit board (pcb) and power switch.Started with a visual inspection then filled tank with water, attached temperature check, plugged in line cord,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.Customer reported issue was not duplicated.Everything operated as it should contrary to the customer complaint.The root cause of the reported issue unable to be determined.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.

• 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): NULL; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13517019
• MDR Text Key: 285572401
• Report Number: 3012307300-2022-03240
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 03/16/2022; 02/07/2023
• Supplement Dates FDA Received: 03/18/2022; 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1