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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS, HF 1500 SUBSYSTEM, WATER PURIFICATION

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VIVONIC GMBH AQUABPLUS, HF 1500 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040105-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2022
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 that the motor protection switch (mps) from an aquabplus 1500 sustained thermal damage. Prior to the user facility opening for the day, the aquabplus 1500 had a t-1 failure of the p1 pump. According to the biomed, the thermal overload switch was tripping in stage 1. To temporarily resolve the issue, they reset it and were then able to use the reverse osmosis (ro) system for the remainder of the day. At the end of the day, as the biomed went to disinfect the ro, the display screen and the red/green light switch began to flash off and on. This happened multiple times until the system completely shut down. The biomed noted a mild burning smell at this time. During their inspection of the aquabplus system, the biomed identified evidence of thermal damage on the motor protection switch (mps) from stage 1. Both the switch and the wiring harness were burnt. The biomed got in touch with a water system specialist and was advised to switch the machine to emergency mode stage 2. The biomed confirmed the machine was operable in stage 2, and they replaced the switch and wiring harness a couple of days later when replacements arrived. The biomed confirmed there was a concentrate pressure low alarm that occurred at the time of the failure. There were no blown fuses in the local power supply and there were no local power grid issues around the time of the events. It was confirmed there was no evidence of any smoke, sparks, or flames. There was also no patient involvement; the biomed confirmed that no treatments were impacted, delayed, or cancelled. The biomed suspects there was ¿too much hard water being dumped into the ro¿. After replacing the mps and wiring harness, the machine issue was confirmed to be resolved. Upon follow-up, the biomed stated the water hardness has been within specification. The biomed stated they would provide photos of the damaged parts via email. Ftp files have already been provided, and the damaged parts were returned via returned goods authorization (rga).
 
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Brand NameAQUABPLUS, HF 1500
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 Key14625105
MDR Text Key293493770
Report Number3010850471-2022-00015
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 User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02040105-US
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received07/02/2022
Was Device Evaluated by Manufacturer? Yes
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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