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U.S. Department of Health and Human Services

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

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VIVONIC GMBH AQUABPLUS, HF 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 04/19/2022
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus 2000 sustained thermal damage. There were no alarms. The aquabplus system was in standby mode at the time of the discovery. The biomed stated they were replacing the level rod (with float) because the disinfection cycle would not complete. Upon lifting the cover, a burnt wire connector was identified on the stage 1 power switch. This occurred after the clinic had closed for the day and there was no patient involvement. There was no evidence of any burning smell, smoke, sparks, or flames. The biomed stated there was nothing wrong with the machine, other than the fact that it would not complete the disinfection cycle. The thermal overload switch was not tripping, and there were no blown fuses in the local power supply. The biomed also confirmed there were no local power grid issues at the time of the event. After replacing the level rod, the machine was able to complete disinfection. The burnt wire connector was not replaced. The biomed was unable to provide the ftp files. The level rod that was replaced was available to be returned for evaluation.
 
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Brand NameAQUABPLUS, HF 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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14356722
MDR Text Key291385511
Report Number3010850471-2022-00010
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 06/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2022
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? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received05/25/2022
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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