MAUDE Adverse Event Report: OAKDALE LEVEL 1 FLUID WARMING SYSTEM - TEMPCHECK; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number	80-01-040
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit was not functioning properly.Patient involvement unknown.
Additional 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.
Additional Manufacturer Narrative
One warmer device was received for investigation.During visual inspection the device was observed to have no damage or anomalies.The reported issue was confirmed during functional testing when the device display would not function.The investigation traced the issue to the device circuit board, which was determined to be faulty.The investigation could not attribute a root cause for the observed condition, but determined it was consistent with wear over extended usage.The circuit board component was replaced.As no manufacturing root cause could be identified, no review of manufacturing device history records was conducted.A review of device confirmed this device has not been in for service previously.

• Brand Name: LEVEL 1 FLUID WARMING SYSTEM - TEMPCHECK
• Common Device Name: 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: 16820188
• Report Number: 3012307300-2023-04628
• Device Sequence Number: 15236880
• Product Code: BSB
• UDI-Device Identifier: 50695085804008
• UDI-Public: 50695085804008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK020043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: 80-01-040
• Device Catalogue Number: 80-01-040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown