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

Model Number HL-90

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

It was reported the device had an lcd did not work.No patient injury reported.

Manufacturer Narrative

Other text: additional information d4 udi is unknown.No product information has been provided to date.This mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Device was received in with cracks along the bottom of the reservoir cover as well as mold, the reservoir tank contains small dark substances with clothlike material, the line cord was worn and device was missing rubber feet.The enclosure contained many black markings and minor paint chippings.The technician installed test disposable l-70 and powered on device.The reported issue was confirmed.The digits flashed once then disappeared on the display.The root cause of the reported issue was found to be faulty electronic assembly.No action taken due to the condition.The device is deemed beyond economical repair and will be scrapped.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMING DEVICE
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• 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; receiving; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 13201452
• MDR Text Key: 285690328
• Report Number: 3012307300-2022-00353
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1