MAUDE Adverse Event Report: MEDIVATORS INC MEDIVATOR/CANTEL ADVANTAGE PLUS ENDOSCOPE WASHER; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number ADVANTAGE PLUS

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 12/13/2022

Event Type  malfunction  

Event Description

Original equipment manufacturer (oem) unable to complete preventative maintenance (pm) on two endoscope washers per oem schedule due to back ordered pm parts.Site has safety and regulatory concern due to missed maintenance for device that sterilized high risk instrument and equipment.

• Brand Name: MEDIVATOR/CANTEL ADVANTAGE PLUS ENDOSCOPE WASHER
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC; minneapolis MN
• MDR Report Key: 15987870
• MDR Text Key: 305685632
• Report Number: MW5113815
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/13/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ADVANTAGE PLUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other