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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 Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
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 portable reverse osmosis (pro) system sustained thermal damage sometime back in (b)(6) 2021 (exact date unknown). The biomed was not present when this happened, but they were told there was a power surge at the hospital. The power surge was followed by a burning smell that was coming from the power outlet the aquac uno h was plugged into. The biomed stated this occurred in the morning, before any patients were put on dialysis. After evaluating the system, it was discovered that one of the three prongs from the power plug of the aquac uno h was fried. The biomed said it looked blackened and melted. In addition, the power outlet itself was burnt, and a capacitor in the power supply blew. No other damaged components were found. The facility discontinued use of the pro device and it was taken to a nearby repair facility where it has remained since. The power supply and power cord were replaced at the repair facility, however, the electrical issues continued. Now, when the device changes modes, it pops the ground fault interrupter (gfi) wall breaker. The biomed has replaced the following parts with known good ones: the motherboard, the motor, and the heater. Each time modes are changed on the pro, it pops the wall breaker. Additionally, when the level rod float in the pro reaches level 3, this also pops the wall breaker. The biomed no longer has any of the parts that were replaced; they were all discarded. The biomed stated there were no blown fuses in the local power supply (at the hospital), at the time of the event. The biomed also confirmed that the thermal overload switch was not tripping. The issue has not been resolved and the biomed needs further assistance troubleshooting. No photos of the damaged components were available for review. The biomed was not aware of any smoke, sparks, or flames occurring at the time of the event. The ftp files have been provided for review. There was no patient involvement associated with the reported event.
 
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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 Key12503060
MDR Text Key272415886
Report Number3010850471-2021-00026
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 company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received10/01/2021
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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