MAUDE Adverse Event Report: OAKDALE LEVEL 1 H-1200 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number 8002950

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that there was overheating with a smell of burnt electronics components.No patient involvement or injury was reported.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device in poor condition due to broken h-31b door, normal wear and tear line cord, and enclosure.The customer stated problem was duplicated.Repair determined that wear and tear on the device was extensive and beyond economical repair.It was therefore decided that the device would not be repaired.The cause of the reported problem could not be determined.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.

• Brand Name: LEVEL 1 H-1200 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; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; loading dock 1; minneapolis, MN 55442
• MDR Report Key: 14075224
• MDR Text Key: 289011179
• Report Number: 3012307300-2022-06165
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8002950
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1