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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 05/17/2022
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 a failure where there was no power to the display of an aquabplus 1500. While troubleshooting the failure, it was revealed that the 24v power supply boards from stage 1 and stage 2 failed. Upon follow-up, the biomed reported that a power surge had occurred at the facility. The biomed was not present when the power surge occurred. The biomed was told that the lights flickered in the break room, and following the power surge, the reverse osmosis (ro) system would not power on. The biomed was called to the facility to perform troubleshooting on the ro. There were no alarm codes displayed on the system. It was confirmed there were no treatments ongoing because the clinic had closed for the day; there was no patient involvement. During troubleshooting, the biomed realized that the 3. 15a fuses from stage 1 and stage 2 had blown and appeared burnt. The biomed replaced the fuses, tried powering on the system, and the fuses blew (and burned) once again. It was then determined that both power supply boards needed to be replaced. The biomed borrowed a spare power supply board from a different clinic and was able to get the system up and running before the clinic opened the next day. Once the spare power supply board was installed in stage 1, the machine was able to pass the t1 test without issue. The biomed ordered an additional power supply for stage 2. The biomed did not have any photos of the burn damage. They confirmed that both power supply boards exhibited burn damage, along with each blown fuse. Per the biomed, the thermal overload switch was not tripping. The biomed also confirmed that there were no blown fuses in the local power supply. The biomed stated the ro was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The ftp machine files were provided for review, and the burnt power supply boards were sent back for further evaluation.
 
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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 Key14629172
MDR Text Key293519360
Report Number3010850471-2022-00016
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 07/07/2022
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? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received06/14/2022
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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