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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 10/18/2021
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 finding thermal damage on components from an aquabplus 2000. While the aquabplus 2000 was being rinsed at the end of the day, the biomed noticed the motor protection switch (mps) was cutting on and off (in phase 1) while dry run protect alarms were occurring. Per the biomed, the power fluctuation to phase 1 caused the 3 black wires going from the mps to the red and green on/off switch to burn and melt. To resolve the reported issue, the biomed replaced the 3 black wires and the red and green on/off switch. As a precaution, it was reported that the power cable would also be replaced. The mps did not exhibit any signs of thermal damage and therefore did not need to be replaced. As part of the repair, the biomed installed a break tank to resolve the issue of low water pressure going to the aquabplus. Other than the charring and melting found on the black wires, the biomed did not find any further damage. There was no evidence of any burning smell, smoke, sparks, or flames. It was believed that the thermal overload switch was not tripping. The biomed stated that a fuse had gone out in the breaker box, but the fuse that went out was associated with phase 2. The biomed did not remember the size of the blown fuse; however, they confirmed that they replaced it and the issue did not reoccur. There were no local power grid issues in the area around the date of the event. Photos of the burnt wires were provided for review, as were the ftp machine files. The damaged parts were reported to be available for return. There was no patient involvement associated with the reported event.
 
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Brand NameAQUABPLUS 2000
Type of DeviceSUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
director of quality
sailauf 63877
GM 63877
Manufacturer (Section G)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
director of quality
sailauf 63877
GM 63877
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key12775908
MDR Text Key280504882
Report Number3010850471-2021-00030
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 12/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02040107-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received11/16/2021
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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