MAUDE Adverse Event Report: MEDIVATORS INC. MEDIVATOR; AUTOMATED ENDOSCOPE REPROCESSOR

Catalog Number 102446

Device Problem Application Program Problem (2880)

Patient Problem No Information (3190)

Event Date 08/25/2016

Event Type  malfunction  

Event Description

Near the end of (b)(6), we inadvertently discovered that the server/software designed to capture the reprocessing data of our medivators does not function consistently on two of our machines at (b)(6) medical center (b)(6).As a result we are missing reprocessing data on an undetermined number of dates, times and pieces of equipment which data we are required to maintain.We are concerned that the vendor was aware of the potential issue and failed to disclose this to us prior to purchasing the server and software package to go with the automated endoscope reprocessor.When contacted to come and help with the issue the vendor disclosed that they had experienced similar issues and suggested that we obtain the software upgrade as soon as its available.It was also newly suggested that the medivator machines be rebooted weekly, an action that can only be accomplished by is upon request from the department each week.

• Brand Name: MEDIVATOR
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; minneapolis MN 55447
• MDR Report Key: 5949028
• MDR Text Key: 54931802
• Report Number: MW5064718
• Device Sequence Number: 3
• Product Code: FEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2016
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102446
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other