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U.S. Department of Health and Human Services

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

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VIVONIC GMBH AQUABPLUS 2000 SUBSYSTEM, WATER PURIFICATION Back to Search Results
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.

 
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Brand NameAQUABPLUS 2000
Type of DeviceSUBSYSTEM, 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 Key7139551
Report Number3010850471-2017-00003
Device Sequence Number1
Product CodeFIP
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 Received12/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberAQUABPLUS 2000
Device Catalogue NumberG02040107-US
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/21/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age mo
Event Location No Information
Date Manufacturer Received03/21/2018
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

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