MAUDE Adverse Event Report: MEDIVATORS INC. CANTEL MEDIVATOR - ADVANTAGE PLUS ADV; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number ADVANTAGE PLUS

Device Problem Protective Measures Problem (3015)

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

Event Date 01/03/2023

Event Type  malfunction  

Event Description

The preventive maintenance on the unit can't be performed due to the medivators pm kit part shortage.Mfg: medivators, inc.Cantel model : advantage plus adv-1008.Reference report #mw5115698, #mw5115700.

• Brand Name: CANTEL MEDIVATOR - ADVANTAGE PLUS ADV
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.; minneapolis MN 55447
• MDR Report Key: 16530598
• MDR Text Key: 311243238
• Report Number: MW5115699
• 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: 03/08/2023

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 Operator: Health Professional
• Device Model Number: ADVANTAGE PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other