MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90; WARMER, THERMAL, INFUSION FLUID

Catalog Number HL-90-INT-230

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

It was reported, that the device was damaged upon opening.No patient involvement or injury was reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), 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.No product was returned.As a result, a complaint investigation / product evaluation and problem confirmation cannot be performed.No root cause could be determined as the complaint could not be confirmed.D4 udi details were unknown.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16824611
• MDR Text Key: 314105208
• Report Number: 3012307300-2023-04640
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K001764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1