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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 Problems Thermal Decomposition of Device (1071); Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 07/11/2020
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 biomedical technician (biomed) at a user facility reported that an aquabplus device had a supply failure t1 test pumps during the second stage. The p1 was defective. The biomed stated that upon troubleshooting the machine issue, they found that the motor protection switch had burnt wires. The biomed stated that there was smoke from the device, however the smoke detectors did not go off. The biomed stated that they did not observe any burning smell, spark, flame, arcing, or any other visible heat or electrical damage related to the burnt wires. The biomed stated that the motor protection switch was replaced, which resolved the device issue, and that the device is back in service without any issues. Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burnt wires on the motor protection switch. The biomed confirmed that there was no patient involvement. The biomed stated that the device has been returned to the manufacturer for physical evaluation.
 
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Brand NameAQUABPLUS 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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key10320028
MDR Text Key200225292
Report Number3010850471-2020-00005
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2020
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040107-US
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received08/12/2020
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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