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

Model Number	8002911
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the h1200 fluid warmer equipment, was in service in a 10 hours surgery, which was supposed to last for 20 hours total, but it was interrupted, the equipment started to send an alarm, it was overheating, it did not permit to restart the process.The equipment presented a leaking at the returning pipe.No patient injury was reported.
Additional Manufacturer Narrative
No product was returned by the customer.As a result, a complaint investigation / product evaluation and problem confirmation cannot be performed.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; col.ciudad satelite; minneapolis, MN 55442
• MDR Report Key: 13950962
• Report Number: 3012307300-2022-05515
• Device Sequence Number: 14571937
• Product Code: BSB
• UDI-Device Identifier: 50695085001872
• UDI-Public: 50695085001872
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: BK020043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 8002911
• Device Catalogue Number: 8002911
• Was Device Available for Evaluation?: No
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2018
• 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