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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.
 
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.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, the ftp machine files were provided for review.Review of the complaint history revealed that the reported event is a known failure pattern.The design of the crimp and blade receptacle will be changed in the new design of the device.Until the new design becomes available, the following should be performed (if not already done): replace the damaged wires of the power cord and replace the wires from the motor protection switch to the overload relay.The motor protection switch could be pre-damaged and it is recommended to replace it to avoid a potential device break down.The investigation determined there was bad electrical contact at the motor protection switch which led to the reported failure.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.The device was found to be conforming to specifications and was released without any discrepancies.The complaint was confirmed based on review of the provided machine files.
 
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Brand Name
AQUABPLUS 2500
Type of Device
SUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
sailauf 63877
GM  63877
MDR Report Key11916414
MDR Text Key258909828
Report Number3010850471-2021-00014
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
PMA/PMN Number
K133829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was 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
Device AgeMO
Date Manufacturer Received06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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