• 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 2500 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 2500 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040108-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 05/22/2017
Event Type  malfunction  
Manufacturer Narrative
The reported complaint is not confirmed as the complaint device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by an employee of the manufacturer vivonic (b)(4). The manufacturer reviewed the details of the complaint, including photographs that were provided by the customer. It was reported that while the customer was troubleshooting the power supply failure, a burnt diode of the interlock relay and a burnt 24v connection line were both discovered by the biomedical technician (biomed). Based on the photograph provided by the customer, vivonic suggests that a suboptimal crimp connection contributed to an increase in resistance and temperature that resulted in the charred 24v connection line. The burnt diode of the interlock relay is alleged to have been caused by an incorrect wiring failure which was attributed to the facility technician. However, no parts or device were returned to the manufacturer for investigation. Therefore, the event remains unconfirmed.
 
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus reverse osmosis machine would not power back on after the power supply shut down. The machine was evaluated at the user facility by the biomed and the connection line 24v and the diode on the interlock relay were found to have burn damage. There was no report of any other heat or burn damage to the machine¿s components. No parts have been made available to be returned to the manufacturer for evaluation. No further information has been made available at this time.
 
Manufacturer Narrative
A plant investigation is in progress. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus reverse osmosis machine would not power back on after the power supply shut down. The machine was evaluated at the user facility by the biomed and the connection line 24v and the diode on the interlock relay were found to have burn damage. There was no report of any other heat or burn damage to the machine¿s components. No parts have been made available to be returned to the manufacturer for evaluation. No further information has been made available at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6916909
MDR Text Key251885545
Report Number3010850471-2017-00001
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,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Biomedical Engineer
Device Catalogue NumberG02040108-US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received11/16/2017
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

-
-