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U.S. Department of Health and Human Services

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

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VIVONIC GMBH AQUABPLUS 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 08/30/2021
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 aquabplus 1500 was experiencing a power problem. The biomed received a call from the facility when they were opening, reporting that the reverse osmosis (ro) system would not power on. During their troubleshooting, the local staff relocated the stage 2 power supply board and cable (going to the motherboard), to stage 1. This resolved the power issue. After doing this, the t1 test was completed without any problems. The biomed went to the clinic to evaluate the ro system. The biomed stated there were no alarm codes. Per the biomed, this was strictly a power-related issue. Upon further inspection, burn marks were identified on the cable connector that goes to the power supply motherboard. Replacement parts (a power supply and cable) were ordered. The reported failure resulted in a minor treatment delay (approximately 15 minutes); however, all patients were able to complete their treatments and none were sent home or to a different clinic. There was no patient harm. Other than the burnt cable connector, there were no additional damaged components found. There was no burning smell, smoke, sparks, or flames. In addition, there were no local power grid issues in the area. The biomed confirmed there were no blown fuses in the local power supply, and the thermal overload switch was not tripping. At the time of follow-up, the machine was fixed and fully operational. The parts were available to be returned for evaluation; the biomed stated they were packaged and ready to be sent back. Photos of the burnt cable connector were provided for review. The biomed was unable to provide the ftp machine files. There was no patient involvement associated with the reported event; the reported failure occurred prior to the start of any treatments.
 
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Brand NameAQUABPLUS 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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key12503057
MDR Text Key272415893
Report Number3010850471-2021-00025
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 company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/14/2021
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 NumberG02040105-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 Received09/24/2021
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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