MAUDE Adverse Event Report: OAKDALE LEVEL 1 FLUID WARMING DEVICE, IRRIGATING SYSTEM; WARMER, THERMAL, INFUSION FLUID

Model Number	H-1129
Medical Device Problem Codes	Leak/Splash (1354); Power Conditioning Problem (1474)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the unit was "tripping" the electrical box in the operating room when it was powered on at the start of a procedure.It was also discovered the unit had a "puddle" underneath it when the problem was investigated.No adverse effects reported.
Additional Manufacturer Narrative
Other, other text: h6 evaluation codes - updated one device was received for investigation with no cuffs, no hi 2 mounting bracket and no ram horn.After further visual inspection, it was found that the ground wire to the back panel was taken off and placed on the pump bracket which is incorrect.Functional testing occurred and was unable to duplicate the unit tripping the electrical box, however, it did verify that the unit was leaving a puddle underneath the device.A crack returned tube caused this leak underneath the device.A manufacturing dhr review was not performed because the device is beyond a year from its manufacture date of 2016-06-12 and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: LEVEL 1 FLUID WARMING DEVICE, IRRIGATING SYSTEM
• Common Device Name: 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: 16899307
• Report Number: 3012307300-2023-05426
• Device Sequence Number: 12127305
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: 50695085812904
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K072080
• 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): 07/26/2023

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: H-1129
• Device Catalogue Number: H-1129
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/03/2023
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2016
• 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