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

Catalog Number CON-HL-90

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Event Description

It was reported the device would not power on.No patient injury reported.

Manufacturer Narrative

Other, other text: additional information d4 udi is unknown.No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter (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.The power switch is missing and so is the input plug on the printed circuit board (pcb) where the switch was plugged into.The technician couldn't even plug a test switch into the pcb.The technician confirmed the essential parts were missing.The root cause of the reported issue was found to be customer damage.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped., corrected data: d4 catalog number,.

Event Description

Additional information received via email on 13-jan-2022: date of event unknown, no additional information available.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• 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; 1040 w jefferson; minneapolis, MN 55442
• MDR Report Key: 13359840
• MDR Text Key: 286372126
• Report Number: 3012307300-2022-01782
• 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: 03/14/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 03/14/2023
• 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