MAUDE Adverse Event Report: MEDIVATORS INC. DSD EDGE; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number DSD EDGE

Device Problem Lack of Maintenance Documentation or Guidelines (2971)

Patient Problem Insufficient Information (4580)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

Original equipment manufacturer (oem) unable to complete preventative maintenance (pm) on 3 medivator units per the schedule set out by the oem due to pm parts backorders.Equipment is on full support (pm and repair) by oem.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: DSD EDGE
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.
• MDR Report Key: 15147759
• MDR Text Key: 297162850
• Report Number: MW5111220
• Device Sequence Number: 3
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/29/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DSD EDGE
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other