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

Catalog Number CON-HL-90

Device Problems Erratic or Intermittent Display (1182); Temperature Problem (3022)

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

Event Date 06/22/2022

Event Type  malfunction  

Event Description

It was reported that the display is cutting out and the temperature is not consistent.No patient involvement was reported.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device presented with corroded drain fitting, cracked tank cover, faded line cord, damaged pole clamp.The customer stated problem was duplicated.The display was intermittent due to faulty pcb (printed circuit board) confirming the customer complaint.Device was not needed so it was scrapped.The cause of the reported problem could not be determined.Product is beyond a year from manufacture date and there was no indication or evidence provided in the complaint of a manufacturing defect, so a dhr (device history review) was not performed.Service history review identified this device has not been in for service in the previous year and there was no indication or evidence provided in the complaint of a service issue.Corrected data: d5: correction: operator of the device: unknown.E4: correction: customer reported to fda: no information.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• 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; receiving dock; minneapolis, MN 55442
• MDR Report Key: 15055760
• MDR Text Key: 300774687
• Report Number: 3012307300-2022-13646
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1