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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUA C UNO H KIT SUBSYSTEM, WATER PURIFICATION

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VIVONIC GMBH AQUA C UNO H KIT 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 05/04/2022
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 finding thermal damage on an aquac uno h system. Initially, it was reported that the reverse osmosis (ro) system had no power to the display. The machine was in standby mode at the time of the failure. Per the biomed, a hospital staff member tried turning on the ro in the morning, and the screen was black. The biomed was not made aware of any machine alarms that occurred. There was no patient involvement associated with the event. The biomed stated the ro is a backup and was not being used at the time. While troubleshooting, the biomed found burn damage on the power supply board, and a burn mark on the metal shield it was up against. The biomed stated that the metal shield separates the hydraulics from the electrical components. The biomed inspected the components on the other side of the shield and found no signs of damage. The biomed said the fuses were all fine and didn¿t need to be replaced. To resolve the reported issue, the biomed replaced the 24vdc and the power supply board. The biomed was able to clean the burn mark off of the metal shield. After replacing the power supply board, the biomed ran an electrical leakage test on the ro and it passed. They also drew samples to test the purity of the water and the results came back ok (within specification). The biomed then disinfected the ro. At the time of follow-up, the ro was fully operational and has not experienced any further issues. The biomed did not know of any local power grid issues and was not aware of any blown fuses in the local power supply. When used, the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The biomed also confirmed that the voltage of the outlets are very stable. The biomed was unsure what may have caused the damage. There was no report of any burning smell, smoke, sparks, or flames. The ftp machine files and a photo were provided for review. The damaged power supply board was returned for further evaluation.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Despite this, thermal damage could clearly be seen in the provided picture. The issue was resolved by replacing the 24vdc power supply. The failure was most likely caused by a power surge from the local power grid. This cannot be identified as a fire hazard as the device is designed and constructed according to the applicable standards of iec 60601-1. The raw materials used, especially the housing, are compliant with the applicable requirements of the fire prevention portion of the standard. The applicable requirements were passed successfully within the approval procedure. The reported event date was not included in the provided machine files. A device history record (dhr) review was performed. The device was found to be conforming to the specifications and was confirmed to be released without any discrepancies. No sample return was required as the provided picture was sufficient. A review of the repair history was not required. Reproducing the reported failure pattern was also not necessary; the reported event can be attributed to a faulty power supply unit and this was confirmed by reviewing the provided picture. A review of the instructions for use (ifu) and service manual (sm) were not required. Based on the information available and the provided picture, the reported event was confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported finding thermal damage on an aquac uno h system. Initially, it was reported that the reverse osmosis (ro) system had no power to the display. The machine was in standby mode at the time of the failure. Per the biomed, a hospital staff member tried turning on the ro in the morning, and the screen was black. The biomed was not made aware of any machine alarms that occurred. There was no patient involvement associated with the event. The biomed stated the ro is a backup and was not being used at the time. While troubleshooting, the biomed found burn damage on the power supply board, and a burn mark on the metal shield it was up against. The biomed stated that the metal shield separates the hydraulics from the electrical components. The biomed inspected the components on the other side of the shield and found no signs of damage. The biomed said the fuses were all fine and didn¿t need to be replaced. To resolve the reported issue, the biomed replaced the 24vdc and the power supply board. The biomed was able to clean the burn mark off of the metal shield. After replacing the power supply board, the biomed ran an electrical leakage test on the ro and it passed. They also drew samples to test the purity of the water and the results came back ok (within specification). The biomed then disinfected the ro. At the time of follow-up, the ro was fully operational and has not experienced any further issues. The biomed did not know of any local power grid issues and was not aware of any blown fuses in the local power supply. When used, the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The biomed also confirmed that the voltage of the outlets are very stable. The biomed was unsure what may have caused the damage. There was no report of any burning smell, smoke, sparks, or flames. The ftp machine files and a photo were provided for review. The damaged power supply board was returned for further evaluation.
 
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Brand NameAQUA C UNO H KIT
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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14583930
MDR Text Key293246470
Report Number3010850471-2022-00014
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,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02000970-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received06/01/2022
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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