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

Catalog Number CON-HL-390

Device Problem Failure to Calibrate (2440)

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

Event Date 11/19/2021

Event Type  malfunction  

Event Description

It was reported that the device would not pass preventative maintenance procedure.No patient was involved.

Manufacturer Narrative

One device was returned for investigation.The returned sample was visually inspected, and the device was noted to have a cracked enclosure and tank cover, the lcd was smashed from the front cover, and parts of the printed circuit board were broken off.The customer?s complaint was confirmed; it was determined that the device could not be calibrated because of a faulty circuit board.It was determined that the cause of the issues was from customer error.Customer tried to adjust the circuit board.No action was taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.The manufacturing dhr 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.

Manufacturer Narrative

One device was returned for investigation.The returned sample was visually inspected, and the device was noted to have a cracked enclosure and tank cover, the lcd was smashed from the front cover, and parts of the printed circuit board were broken off.The customer?s complaint was confirmed; it was determined that the device could not be calibrated because of a faulty circuit board.It was determined that the cause of the issues was from customer error.Customer tried to adjust the circuit board.No action was taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.The manufacturing dhr 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.

• 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): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13599406
• MDR Text Key: 286655880
• Report Number: 3012307300-2021-13363
• 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: 03/22/2022

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-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1