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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2500 SUBSYSTEM, WATER PURIFICATION

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VIVONIC GMBH AQUABPLUS 2500 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040108-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
An area technical operations manager (atom) reported that an aquabplus 2500 had no power. They reported that the system would not turn on in the morning. This occurred prior to any patients beginning their treatments, and therefore, there was no patient involvement. Although some treatments were delayed, there were no missed treatments. Upon further inspection of the machine, thermal damage was found on the l2 cable connected to the motor protection switch. The atom stated the l2 cable was badly burnt, and l1 and l3 were discolored. In addition, l2 was found to be loose. The atom stated it was not securely connected to the switch. Furthermore, it was found that the main fuse on the electrical outlet (where power is supplied to stage 1) was blown. The atom also noticed that the middle light was out on the surge protector (not a vivonic part) installed next to the main power outlet. The atom was unsure if this was related to the motor protection switch failure, however, they stated that all three lights are supposed to illuminate (green). To resolve the reported issue, the motor protection switch and cables were replaced. The damaged parts were reportedly returned for manufacturer evaluation. There were no further issues reported with the system after the repair.
 
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Brand NameAQUABPLUS 2500
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 Key11914750
MDR Text Key253566987
Report Number3010850471-2021-00012
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 07/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040108-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 Received06/07/2021
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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