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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 Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2021
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 the motor protection switch (mps) from an aquabplus 2500 sustained thermal damage. The biomed stated the display screen was blinking, and the machine would not go into operating mode. During evaluation of the system, the biomed discovered that the wire connectors (or cable lugs) on the back of the motor protection switch (mps) were burnt. There was no evidence of any burning smell, smoke, sparks, or flames. There were no alarm codes on the system. The biomed was unsure if the screen issues were caused by the burnt wire connectors on the mps, or the sd card which was reported to be corrupt. However, when the biomed replaced the sd card the screen issues went away. The biomed still intends to replace the mps and wires and confirmed that replacements were ordered. The biomed stated the thermal overload switch was not tripping, and there were no local power grid issues on the event date. Additionally, there were no blown fuses in the local power supply. The biomed was unable to download the machine files because the sd card was corrupt. The biomed stated they would provide photos of the thermal damage; but to date no photos have been provided. The biomed stated they would send back all replaced parts for evaluation. There was no patient involvement associated with the reported 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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key12643309
MDR Text Key276823395
Report Number3010850471-2021-00028
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 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02040108-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received10/29/2021
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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