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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 Patient Involvement (2645)
Event Date 05/29/2017
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. The facility biomedical technician discovered a burnt connector at the 24v power supply unit. The general function of the device was not impacted by the damage to this specific component. Based on the photograph provided by the customer, vivonic states that the component was likely burnt due to a suboptimal crimp contact. The crimp contact caused an increase in electrical resistance which resulted in the heating and burning of the connector plastic. However, as the actual device was not returned to the manufacturer for investigation and there was no on-site service provided, the event remains unconfirmed.
 
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus reverse osmosis machine and the connection line 24v was 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 and the connection line 24v was 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.
 
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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
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6917064
MDR Text Key251885922
Report Number3010850471-2017-00002
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

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