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

Model Number HL-390

Device Problem Defective Alarm (1014)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the warmer over-temp alarm did not activate when pushed and held.Patient involvement unknown.

Manufacturer Narrative

No information has been provided to date.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.

Event Description

Additional information received via email.The device came in without a serial number so we cannot verify the serial number.The investigation was completed as no product returned.

Manufacturer Narrative

G1 email is: (b)(4).Product was not returned, and no photographic evidence provided to aid in this investigation.As a result, product evaluation and problem confirmation cannot be performed.The exact cause could not be determined; however, based on the reported problem, the most probable cause would be the over temperature alarm calibration potentiometer setting was out of range.The product's history records of the reported serial number were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action was taken as the device was not returned.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16780686
• MDR Text Key: 313937703
• Report Number: 3012307300-2023-04344
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1