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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 Arcing (2583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2021
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 a stage 1 overload protector that kept tripping in supply mode. There was loose contact on the l2 female disconnect cable going to the motor protection switch (mps), and it was reported that this caused arcing. It took three system resets to get the motor running. The l2 connector needed to be tightened for the overload protector to stop tripping. Reportedly, the insulation cracked when they tried to adjust the female disconnect. It was reported that discoloration was also visible on the cable. The atom covered the cracks with black insulation tape. It was reported that the machine has been returned to service. There was no report of patient involvement associated with the event.
 
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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 Key11916414
MDR Text Key258909828
Report Number3010850471-2021-00014
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 06/28/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received06/03/2021
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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