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U.S. Department of Health and Human Services

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

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VIVONIC GMBH AQUABPLUS, HF 2000 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Model Number AQUABPLUS
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2022
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 reported to fresenius technical support that an aquabplus, hf 2000 experienced no power to the display. Upon troubleshooting, a burnt wire was discovered on the power supply board. The biomedical technician removed the power supply from stage 2 and placed it into the stage 1. The biomedical technician also removed the cable from the power supply board to the mother board, and replaced the cable with the red/blue cable from stage 2 to resolve the reported issue and the machine was returned to service. There was no patient involvement, harm, or adverse events reported as a result of this issue. After the documented follow up attempts, no further information has become available and no response from the customer has been received. If additional information becomes available, the file will be updated and processed accordingly.
 
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Brand NameAQUABPLUS, HF 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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key15140907
MDR Text Key297001518
Report Number3010850471-2022-00017
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 User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAQUABPLUS
Device Catalogue NumberG02040107-US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received08/10/2022
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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