MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Catalog Number CON-HL-390

Device Problem Power Problem (3010)

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

Event Type  malfunction  

Event Description

It was reported that the power cord ripped out of the unit.No patient injury was reported.Additional information was requested; however, no further information was received.

Manufacturer Narrative

A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Udi unknown, no product information has been provided to date.

Manufacturer Narrative

Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.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.Visual inspection found power cord missing, corroded drain fitting, cracked water tank cover and enclosure, and old style printed circuit board (pcb).Functional testing could not be performed because the power cord is missing.The root cause of the reported issue was found to be customer damage.Due to the age and condition of the device it has been deemed beyond economical repair and will be scrapped.Additional event information received indicating no adverse effects.

Event Description

Additional info received via email 22-aug-2022.No adverse effects.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• 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: 15221921
• MDR Text Key: 300129434
• Report Number: 3012307300-2022-15336
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1