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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 Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/05/2021
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 an aquabplus 2000 would not power on. The local staff had indicated there was a power disruption of unknown cause and the facilitys generator kicked in. The generator reportedly gave a power surge to the system, causing the 24 v power supply unit on stage 1 to fail. The power supply failure then caused the (3. 15 a) fuse that feeds it to blow. They determined this because the fuse was replaced before the power supply, and the fuse blew again. Upon further inspection it was noted that the cable, which connects from the motor protection switch (mps) to the power contactor, was burnt. The 24 v supply was taken from the side and placed on the side. This allowed the system to operate normally. The facility ordered a new 24 v supply, and the cable that feeds the motor protection switch (mps). There were no corresponding alarm codes that occurred during the failure. There was no report of smoke, and there was nobody in the water room at the time of the event to notice any sparks. The failure did not occur while patients were undergoing treatment, and therefore, there was no patient involvement. Once the replacement parts arrive, the 24 v supply from the primary stage will be returned for evaluation. A sample is expected to be sent back.
 
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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 Key12021968
MDR Text Key257107596
Report Number3010850471-2021-00017
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 company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
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 Received07/06/2021
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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