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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 1000 SUBSYSTEM, WATER PURIFICATION

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VIVONIC GMBH AQUABPLUS 1000 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040103-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
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 1000 sustained thermal damage during heat disinfect. The system was running in heat disinfect, and before concluding, it had to be manually put into cool-down. The atom stated there must have been some sort of interruption, but it was unknown if there were alarms. Approximately ten minutes later, the screen went blank, and the system powered down. The machine would not power back on after this. During troubleshooting, it was discovered that the power switch had overheated. There was a burning smell noted, and charring/thermal damage was present on the wiring and spade connectors on the back side of the motor protection switch. There was no evidence of any smoke, sparks, or flames. The atom confirmed the thermal overload switch was not tripping, and there were no local power grid issues in the area on the event date. In addition to the thermal damage at the motor protection switch, a blown 25 amp fuse was found in the local power supply. To resolve the reported issue, the motor protection switch was replaced along with the blown fuse. New wiring was also ordered and will be replaced when received. The atom confirmed the motor protection switch was available to be returned for evaluation. Photos of the thermal damage were provided for review, and the ftp files were as well. There was no patient involvement associated with the reported event.
 
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Brand NameAQUABPLUS 1000
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 Key12447452
MDR Text Key270558583
Report Number3010850471-2021-00023
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,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040103-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 Received10/13/2021
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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