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U.S. Department of Health and Human Services

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

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VIVONIC GMBH AQUABPLUS, HF 2500 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040108-US
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
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 (biomed) reported that an aquabplus 2500 had no display and would not power on in the morning. The machine had been in standby mode prior to this failure occurring. There were no machine alarms to report. While inspecting the machine, the biomed identified blown fuses on the stage 1 power supply board. The biomed replaced two 3. 15a fuses from the power supply board. After doing so, when the motor protection switch (mps) was turned on, sparks were noticed coming from the power supply board. The biomed then tried switching the power supply from stage 2 to stage 1, but this did not resolve the issue. As a result, the power supply board from stage 1 was replaced. The biomed did not notice any visible burn damage on the power supply board. However, they did notice a burning smell. There was no evidence of any smoke or flames. It was confirmed that the thermal overload was not tripping. In addition, there were no local power grid issues at the time of the event. No patients were in treatment when this occurred, and therefore there was no patient injury or harm. The machine was confirmed to be fully operational at the time of follow-up. The ftp files were provided for review and the power supply board was reportedly available to be returned for evaluation.
 
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Brand NameAQUABPLUS, HF 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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key14188182
MDR Text Key290528634
Report Number3010850471-2022-00009
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 User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02040108-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received05/04/2022
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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