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

Model Number HL-90

Device Problem Failure to Power Up (1476)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported that the equipment did not switch on.The customer said that it was "out of order".Steps taken to resolve the issue was "change hotline".The problem was not resolved.There was no patient involved, no harm or injury.

Manufacturer Narrative

D3, g1,2 email is: (b)(6).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.

Manufacturer Narrative

Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(6).One device was received in good condition, small tears, and wears on the device.Per functional testing, when the start switch was pressed nothing happened.The device was opened, and the printed circuit board (pcb) was removed it was noticed that the start switch was broken.The complaint was confirmed.The root cause was the start switch from the pcb was broken related to service and repair.The product's history records were reviewed and identified that the device returned after one month of the prior repair on (b)(6) 2023, where preventive maintenance was performed, and the device passed all functional tests including power-on test.However, service failed to implement the corrective action which was to replace the outdated pcb board with the redesigned pcb board that includes a standalone power switch and added retainer to reinforce the casing to prevent power switch damage.A new pcb was installed the device was fully functional.The new model from the mainboard was installed and the device passed all functional and delivery tests.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert
• MDR Report Key: 18283649
• MDR Text Key: 329950448
• Report Number: 3012307300-2023-10942
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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 Model Number: HL-90
• Device Catalogue Number: HL-90-PORT-230
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/20/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1