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

Model Number DSD EDGE

Device Problem Device Difficult to Maintain (3134)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

Original equipment manufacturer (oem) unable to complete preventative maintenance (pm) on medivator unit per the schedule set out by the oem due to pm parts backorders and/or staff availability.Equipment is on full support (pm and repair) by oem.Site has safety and regulatory concerns due to missed maintenance for devices that sterilize equipment.Serial number: (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: 15915854
• MDR Text Key: 304919703
• Report Number: MW5113616
• 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: 11/30/2022

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: DSD EDGE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other