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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
Catalog Number G02040107-US
Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585); Arcing (2583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (biomed) reported that the red/green power button on an aquabplus 2000 had tripped. The aquabplus was in standby mode when this occurred. There were no alarms. After the power button tripped, there was a flash of light that was seen followed by a small amount of smoke and a burning smell. The hood was closed so they were unable to identify the source of the flashing light. The system was immediately unplugged. Upon further inspection, the biomed identified melting and burn damage on many of the cables that connect the motor protection switch to the contactor. One of the cables had burned all the way through to the wire. Three photos were provided for review and this was depicted in one of them. To resolve the reported issue, the biomed replaced the motor protection switch, the damaged cables, and the power contactor. The replaced parts were reportedly returned for manufacturer evaluation. In addition, the ftp machine files were provided to the manufacturer for review. There was no patient involvement associated with the reported event.
 
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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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11682372
MDR Text Key245906459
Report Number3010850471-2021-00009
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,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040107-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received04/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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