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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 (1385); Sparking (2595)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2017
Event Type  malfunction  
Manufacturer Narrative
Date returned to manufacturer added. The protection switch from the reverse osmosis (ro) machine was returned to the manufacturer for physical evaluation. A visual examination was performed on the switch. The switch was disassembled and a deformity of the plastic rocker was observed. The deformation caused an incomplete closure of the electrical contact from one of the three line conductors. An electrical test was performed on the device which confirmed that one line was not activated. The manufacturer found the machine to have been conforming to specification. Based on concentrate pressure evaluation at the manufacturing site during final release and information regarding the customer site connection, the manufacturer concluded that the electrical connection at the power supply was incorrect performed at the customer site. The manufacturer states that the device was functioning at the customer site without reaching the intended concentrate pressure; however, the electrical phase connection would be hardly detectable and perhaps not suspected. There would be a final high current at one of the phases, which would be generating the overheating leading to the deformation of the switch component. As a consequence of the air gap of the electrical contact, the motor would only operator with two line conductors and trip the motor protection switch, which would lead to customer observance of the issue. The motor protection switch was replaced on the ro unit at the customer site and the rotation direction was corrected. There is no indication of any systemic design, material, or manufacturing related issue. The investigation into the cause of the complaint was able to confirm the reported event. The visual examination and electrical testing of the protection switch confirmed that the part sustained heat damage. Therefore, the complaint is confirmed.
 
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
MDR Text Key254790953
Report Number3010850471-2017-00003
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133829
Number of Events Reported1
Summary Report (Y/N)N
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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