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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, HF 2000
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2022
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 technical support that the motor protection switch keeps tripping on an aqua b plus device. The biomedical technician stated the issue was resolved by replacing the motor protection switch and the three black wires running from the switch to the contactor. The charred switch was noticed after the switch tripped during use that day. Patients were undergoing treatment at the time this was discovered, however and there was no harm to any patients or individuals because of this malfunction. Patients were able to complete treatment with no adverse events or necessary medical intervention. The biomedical technician reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed; only charring. There was no damage observed on any other components. The biomedical technician stated the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The motor protection switch and associated wires were replaced to resolve the reported issue and the machine has been returned to service. Photos have been provided and it was reported that the motor protection switch is available to be returned for evaluation. Ftp files were provided for review.
 
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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 Key15314806
MDR Text Key298855009
Report Number3010850471-2022-00018
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 09/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAQUABPLUS, HF 2000
Device Catalogue NumberG02040107-US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received09/10/2022
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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