MAUDE Adverse Event Report: OAKDALE NORMOFLO IRRIGATION FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number H1100

Device Problem Power Problem (3010)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that the fluids spin every time the up and down key was pressed.

Manufacturer Narrative

Other, other text: b5: additional info received via email (b)(6)2022.Event date was updated.No patient involvement was reported.H6: event problem and evaluation codes: updated.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Received device in poor conditions due to crack enclosure, wear and tear heaters, drain valve, and line cord.Reported problem duplicated by pressing the keypad arrow up and actuator pole spins upwards and downwards.Faulty actuator pole caused the problem.The root cause of the reported issue was not able to be determined.Actions were taken to mitigate the reported issue: replaced actuator pole.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.

• Brand Name: NORMOFLO IRRIGATION 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; minneapolis, MN 55442
• MDR Report Key: 14518502
• MDR Text Key: 292823608
• Report Number: 3012307300-2022-09790
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072080
• 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,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1