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U.S. Department of Health and Human Services

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

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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts have been received by the manufacturer for physical evaluation. A review for similar complaints is not required as the failure pattern is known, and capa projects cover this failure pattern. The design of the crimp and blade receptacle will be changed in the new design. The reported event could be confirmed by reviewing the machine files. In addition, the reported damage was clearly visible in the provided picture. Numerous power off/on failures around the event date were found during review of the machine files. The issue was caused by a bad electrical contact which resulted in overheating of the blade receptacle and wire connection. One factor that contributes to this is the neglected cooling time of the motor protection switch. The connecting cables / flat receptacles and the motor protection switch heat up and then heat damage occurs. No general problem with the local power supply could be seen in the machine files. Per review of the instructions for use (ifu), the regular visual inspection is not user related, and the cooling time to be observed is in the ifu. Review of the service manual (sm) determined that regular visual inspections are adequately addressed. The device history records (dhr) were also reviewed, and the device was found to be confirming to the specifications and released without any discrepancies. Based on the provided photo and the machine files, the reported problem was able to be confirmed. The issue was resolved by replacing the motor protection switch and cables.
 
Event Description
A biomedical technician (biomed) reported that the motor protection switch from an aquabplus 2000 was tripping during supply mode. Upon evaluation of the system, burnt cables from the motor protection switch to the power contactor were found. The biomed ordered replacement parts and then visited a nearby clinic to acquire a spare motor protection switch (mps). The biomed cut off the burnt terminal end of the cable from the motor contactor and attached a new connector to the terminal end. After installing the new switch and repaired cables, the machine was working. After the replacements arrived (mps and cable), the biomed removed the temporary parts and installed the new ones. The thermal damage was on the connector end of the cables and the input on the switch. Other parts were stained by the burnt cable, but not burnt or damaged. The biomed did not observe any smoke or flames. No other damage was noted. The replaced parts were returned via returned goods authorization (rga) and the ftp files were provided for review.
 
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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 Key11916223
MDR Text Key253609020
Report Number3010850471-2021-00013
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
Report Date 06/01/2021
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 NumberG02040107-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 Received05/11/2021
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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