MAUDE Adverse Event Report: MEDIVATORS ADVANTAGE PLUS; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Chills (2191)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

A facility reported two patients experiencing fever and chills after endoscopy procedures performed with endoscopes disinfected in their advantage plus automated endoscope reprocessor.No errors were reported during the reprocessing cycles and the facility reported following proper manual cleaning processes.It is unknown the cause of the reported sickness.The facility reported they were going to run a test cycle with the machine and report back to medivators if any errors were presented.The facility has not reported back.Medivators ra has made multiple attempts to contact the facility for further information regarding potential issues with the machine and the status of the patients.Medivators field service engineer visited the facility to service a different machine and reported the facility did not mention anything related to this incident.The facility has since scheduled a preventative maintenance service for this machine.The cause of the reported patient sickness remains unknown.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported two patients experiencing fever and chills after endoscopy procedures performed with endoscopes disinfected in their advantage plus automated endoscope reprocessor.No errors were reported during the reprocessing cycles and the facility reported following proper manual cleaning processes.It is unknown the cause of the reported sickness.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7488662
• MDR Text Key: 107409850
• Report Number: 2150060-2018-00036
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other