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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 10/18/2021
Event Type  malfunction  
Event Description
A user facility biomedical technician (biomed) reported that the motor protection switch (mps) from an aquabplus 2000 was tripping in stage 1. The system had just finished heat disinfect and was in cool-down when it powered off. The biomed did not think there were any alarms that occurred in conjunction with the tripping mps. This occurred early in the morning, before any treatments had started. Some treatments were delayed by approximately 30 minutes, but all patients were able to complete their treatments after the reverse osmosis (ro) machine was fixed. To resolve the reported issue, the biomed replaced the mps. Upon further inspection of the mps, charring was found on one of the metal prongs. The biomed stated that it looked burnt (or charred); however, there was no evidence of any burning smell, arcing, smoke, sparks, or flames. There were no blown fuses in the local power supply, and there were no power grid issues in the area around the date of the event. The biomed reported that the mps was available to be returned for manufacturer evaluation. A photo of the burnt metal prong was provided for review.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
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Brand NameAQUABPLUS 2000
Type of DeviceSUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
director of quality
sailauf 63877
GM 63877
Manufacturer (Section G)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
director of quality
sailauf 63877
GM 63877
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key12775712
MDR Text Key280505000
Report Number3010850471-2021-00029
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 User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02040107-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received11/16/2021
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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