MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2000 SUBSYSTEM, WATER PURIFICATION

Model Number AQUABPLUS 2000

Device Problems Melted; Sparking

Event Date 12/01/2017

Event Type  Malfunction  

Manufacturer Narrative

A plant investigation is in progress. A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

An installation logistics manager for vivonics reported that an aquabplus reverse osmosis machine underwent troubleshooting for a power failure. During machine repair, the manager had discovered that the power-switch terminal connections were melted. There was no report of heat damage to the machine¿s other components. The area technical operations manager did report evidence of arching. The power-switch is being returned to the manufacturer for physical evaluation. No further information has been made available at this time.

• Brand Name: AQUABPLUS 2000
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• Manufacturer (Section G): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham , MA 02451 ; 7816999499
• MDR Report Key: 7139551
• Report Number: 3010850471-2017-00003
• Device Sequence Number: 1
• Product Code: FIP
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/21/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: OTHER
• Device MODEL Number: AQUABPLUS 2000
• Device Catalogue Number: G02040107-US
• Device LOT Number: N/A
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Device Age: mo
• Event Location: No Information
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse