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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 Smoking (1585); Arcing (2583); Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
An area technical operations manager (atom) reported that an aquabplus 2500 from one of their facilities had a motor protection switch failure. It was reported that the power on the system tripped and the machine would not run. Simultaneously, smoke was seen coming from the thermal contactor below the motor protection switch. The atom stated that it was not a lot of smoke and confirmed that the smoke detector did not go off. A burning smell was also noticed. The atom tried turning the machine back on to run it in emergency mode. As they did this, sparks and arcing were noted coming from the wires down by the contactor. The atom stated that the hood of the reverse osmosis (ro) system was closed, so they were unable to see inside of it. There were no reports of flames. In addition, there were no reported alarms. Patients were in treatment when the failure occurred, but there were no adverse events as a result. The atom stated the facility has two separate ro systems, and the patients who were in treatment were relocated to the other half of the treatment floor where they utilized the other ro system to complete their treatments. The event did not result in any incomplete treatments. To repair the aquabplus 2500, the atom replaced the motor protection switch, the thermal contactor, the relay, and ancillary wiring. The atom stated the damaged parts were returned for manufacturer evaluation. The aquabplus 2500 was returned to service and reported to be fully operational. As patients do not hook up to ro systems, there is no direct patient involvement associated with this event.
 
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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 Key11605865
MDR Text Key243494082
Report Number3010850471-2021-00008
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 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040108-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 Received04/13/2021
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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