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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 Patient Involvement (2645)
Event Date 11/17/2020
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 user facility's biomedical technician (biomed) reported that there was no power on the display of an aquabplus 2500 system. The system was in standby mode at the time of the reported failure. No alarms occurred during the event. While troubleshooting the issue, a burnt connection was identified on the power supply connection cable. The biomed replaced the power supply unit and cable with those from another machine, and ordered replacements. The replaced parts were reportedly returned to the manufacturer 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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key10915166
MDR Text Key218624401
Report Number3010850471-2020-00012
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 01/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2020
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 Received12/11/2020
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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