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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUAC UNO H SUBSYSTEM, WATER PURIFICATION

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VIVONIC GMBH AQUAC UNO H SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02000970-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2021
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 an aquac uno h had no power. To resolve the reported issue, the biomed replaced the 24v power control board. After replacing the part, the machine was subsequently returned to service. Upon careful inspection of the part, the biomed identified discoloration which they believed to be heat damage located on the backside of the 24v power control board. The biomed did not have any photos of the damaged part to provide. The faulty part was returned to the manufacturer for evaluation. There was no patient involvement associated with the reported issue.
 
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Brand NameAQUAC UNO H
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 Key11379493
MDR Text Key233523152
Report Number3010850471-2021-00006
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143617
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02000970-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 Received03/16/2021
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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