MAUDE Adverse Event Report: OAKDALE LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Catalog Number 8002950

Device Problems Temperature Problem (3022); Key or Button Unresponsive/not Working (4063)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the device had a temperature control issue.Unable to adjust to a lower level and some of the test buttons were not working.Patient involvement unknown.

Manufacturer Narrative

Other, other text: b3: date of event is unknown, 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.

Manufacturer Narrative

Other text: h3, h6: event methods, evaluation, and conclusion codes: updated.One warmer device was received for investigation.During visual inspection the device was found to have an outdated model of clear float switch.The air detector door was partially disassembled and reassembled incorrectly.The reported issue was confirmed during functional testing when the lcd could not be adjusted, and the test buttons of the membrane switch were nonfunctional.The investigation traced the issue to the device circuit board, which was determined to be faulty, however, no root cause could be identified for this condition.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The membrane switch, circuit board, o-rings, and fan guard were replaced and the air detector door was reassembled.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17432287
• MDR Text Key: 320121576
• Report Number: 3012307300-2023-07644
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: 50695085829506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020043
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1