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

Catalog Number CON-HL-90

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Manufacturer Narrative

One fluid warmer was received for evaluation in relation to the reported event.Device was received in with build-up in the reservoir tank.Damages made to the front cover, display label and reservoir cover around the screws.Line cord is discolored and the enclosure contains a crack around the drain fitting.Functional testing of the device was unable to confirm or replicate the reported event.The device powered on as expected.Root cause was unable to be determined as the reported event was not confirmed.A 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.

Event Description

It was reported that during testing, the device would not power on.There was not patient involvement reported.

Manufacturer Narrative

One fluid warmer was received for evaluation in relation to the reported event.Device was received in with build-up in the reservoir tank.Damages made to the front cover, display label and reservoir cover around the screws.Line cord is discolored and the enclosure contains a crack around the drain fitting.Functional testing of the device was unable to confirm or replicate the reported event.The device powered on as expected.Root cause was unable to be determined as the reported event was not confirmed.A 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.

Event Description

It was reported that during testing, the device would not power on.There was not patient involvement reported.

• 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: 13579784
• MDR Text Key: 285999878
• Report Number: 3012307300-2022-03841
• 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
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• 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: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1