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

Model Number DSD-201

Device Problem Lack of Maintenance Documentation or Guidelines (2971)

Patient Problem Insufficient Information (4580)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

Original equipment manufacturer (oem) unable to complete preventative maintenance (pm) on 2 medivator endoscope washer units at (b)(6) hospital, per the schedule set out by the oem due to staffing issues.Site has safety and regulatory concern due to missed maintenance for devices that sterilize equipment.Serial numbers: (b)(4).Fda safety report id # (b)(4).

• Brand Name: MEDIVATOR/CANTEL ENDOSCOPE WASHER
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): CANTEL / MEDIVATORS INC.
• MDR Report Key: 15348150
• MDR Text Key: 299307332
• Report Number: MW5111841
• 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: 08/30/2022
• 2 Devices were Involved in the Event: 1 2

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: DSD-201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other