• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2000 SUBSYSTEM, WATER PURIFICATION

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VIVONIC GMBH AQUABPLUS 2000 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040107-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 12/13/2020
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Review of the complaint history revealed that the reported event is a known problem. The reported event was confirmed based on a photo that was provided of the power supply cable. Most likely, the issue was caused by an electrical connection issue (which could lead to a power outage in the worst-case scenario). Review of the instructions for use (ifu) was not required because the issue was not user related. However, a review of the service manual was performed. This review revealed that part of the technical safety check consists of visually inspecting the aquabplus before use. A device history record (dhr) review was also performed. The device was found to be conforming to the specifications for an aquabplus, and was confirmed to be released without any discrepancies. Review of the repair history was not required. Since the reported issue is a known problem, reproduction of the failure was not required. Based on the provided photo, the reported problem was able to be confirmed. The issue was resolved onsite by replacing the 24v power supply cable.
 
Event Description
A user facility biomedical technician (bmt) reported finding discoloration on the connector of a 24-volt power supply cable from an aquabplus 2000 system. The connector was described as brownish looking. Upon further follow-up, it was reported that the discoloration was caused by overheating. It was suspected that there was a "high voltage spike in the area. To resolve the reported issue, the cable was replaced. The sample was not available to be returned for physical evaluation. A photo of the cable was provided for review. There was no reported patient involvement associated with the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAQUABPLUS 2000
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 Key11260465
MDR Text Key229686928
Report Number3010850471-2021-00004
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
Type of Report Initial
Report Date 02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040107-US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received01/13/2021
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

-
-