MAUDE Adverse Event Report: OAKDALE HOTLINE 2 FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number HL-90

Device Problem Intermittent Loss of Power (4016)

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

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted, which indicated that all inspections were completed, and no issues were noted during manufacturing.A product sample was received for evaluation.Visual inspection was performed.Dirty enclosure, scuffed front cover, rusted drain fitting, missing screws and worn out line cord was observed by the technician.The reported issue of unit cutting in and out of power was duplicated.The root cause of reported was found to be loose wire from line cord connecting to the main board.The technician confirmed that the device was beyond repair due to age and condition of the device.The device will be scrapped as it is not economical to repair the device.G5 unique identifier is unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms (b)(4).

Event Description

It was reported that the device cuts in and out when user moves the power cord.No patient injury was reported.

• Brand Name: HOTLINE 2 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; minneapolis, MN 55442
• MDR Report Key: 15300192
• MDR Text Key: 305279482
• Report Number: 3012307300-2022-16356
• 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
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• 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