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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2500 SUBSYSTEM, WATER PURIFICATION

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VIVONIC GMBH AQUABPLUS 2500 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040108-US
Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585); Arcing (2583)
Patient Problem No Patient Involvement (2645)
Event Date 07/13/2020
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 an aquabplus 2500 system was experiencing power issues. Upon further investigation, it was reported that evidence of burn damage was present on the stage 1 power switch and wires. An area technical operations manager (atom) went onsite to evaluate the system. The atom confirmed there was thermal damage on all of the wire connectors from stage 1, in addition to parts of their wires. There was also burn damage found on one of the wire connectors from stage 2, along with part of its wire. According to the atom, there was also evidence of smoke and possible arcing. The power switch and wire connectors were replaced, and any burnt and/or melted wires were cut back. There were no alarms that occurred in conjunction with the reported issue. The damaged components, which were all original fresenius parts, were not available to be returned for evaluation. It was confirmed there was no patient injury or harm as a result of the reported issue.
 
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Brand NameAQUABPLUS 2500
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 Key10681100
MDR Text Key211421350
Report Number3010850471-2020-00007
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 11/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2020
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040108-US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received10/31/2020
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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