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

Catalog Number CON-HL-90

Device Problem Power Problem (3010)

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

Event Date 07/27/2021

Event Type  malfunction  

Event Description

Information received a smiths medical fluid warming|level 1 hotline low flow systems - hl-90 will not power on.Issue discovered during set up and no patient involvement.

Event Description

Additional information received 23 august 2021 (email):.Issue was discovered (b)(6) 2021 during setup.No patient involvement.

Manufacturer Narrative

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.Cracked tank cover, broken front cover, and damaged 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 duplicated.The power switch was damaged but is still operational.The root cause of the reported issue was found to be design and customer damage from regular use.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.A corrective and preventative action has been opened to address the reported issue.

• 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
• MDR Report Key: 12372783
• MDR Text Key: 269791185
• Report Number: 3012307300-2021-08872
• 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
• Report Date: 03/01/2023

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
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1