MAUDE Adverse Event Report: ECOLAB/MICROTEK INC MICROTEK; IRRIGATION SOLUTION WARMER

Model Number ORS-2038D

Device Problem Material Puncture/Hole (1504)

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

Event Date 04/15/2022

Event Type  malfunction  

Event Description

Iy was reported that the or solutions inc.Ecolab ors-2038d solution warmer was found to be defective.It was set on a very low temperature, but still manage to melt the plastic drapes and burn through them.No patient injury, infections or complications were reported.

• Brand Name: MICROTEK
• Type of Device: IRRIGATION SOLUTION WARMER
• Manufacturer (Section D): ECOLAB/MICROTEK INC; 1 ecolab place; st. paul MN 55102
• Manufacturer (Section G): MANUFACTURING ONE, LLC; 14851 stonecroft center ct.; chantilly VA 20151
• Manufacturer Contact: yarina montas ; 1 ecolab place; st. paul, MN 55102
• MDR Report Key: 18899835
• MDR Text Key: 337644621
• Report Number: 3014342658-2024-00001
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/13/2024

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 Model Number: ORS-2038D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1