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

Model Number H-1129

Device Problems Leak/Splash (1354); Power Conditioning Problem (1474)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 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.

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
• 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: 16899307
• MDR Text Key: 314892555
• Report Number: 3012307300-2023-05426
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: 50695085812904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072080
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1