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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 1500 SUBSYSTEM, WATER PURIFICATION

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VIVONIC GMBH AQUABPLUS 1500 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040105-US
Device Problems Thermal Decomposition of Device (1071); Arcing (2583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (biomed) reported finding thermal damage on the l2 cable going from the motor protection switch (mps) to the power contactor on an aquabplus 1500. Someone from the clinical staff noticed a yellow warning light on the reverse osmosis (ro) monitor on the treatment floor, and the biomed went in the back to further investigation. The biomed discovered that the concentrate pressure was too low, and the aquabplus 1500 was giving the alarm code w-02-51-03. Upon further inspection, the biomed found charring on the l2 cable at the mps. All cables connecting the mps to the power contactor were loose, but the charred (or burnt) cable was the loosest. The biomed disconnected power from stage 2 and then replaced the mps and the burnt cable. The spade connectors on the cables were then tightened, and the stage 2 pump resumed function. There was no patient injury or harm, and no missed treatments. Treatments were not impacted during the repair because the ro continued to operate under stage 1. There was no evidence of any burning smell, smoke, sparks, or flames. The biomed confirmed there were no local power grid issues in the area around the time of the event. The biomed checked the local power supply and confirmed that there were no blown fuses there. It was also confirmed that the thermal overload switch was not tripping. The suspected cause of the failure was the loose cables. The loosest cable was the one that had thermal damage, and its suspected that arcing may have occurred at this connection. A photo of the charred cable was provided for review, as were the machine data files. The mps and burnt cable were not available to be returned for manufacturer evaluation as they were discarded.
 
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Brand NameAQUABPLUS 1500
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 Key12457524
MDR Text Key270983063
Report Number3010850471-2021-00024
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 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040105-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 Received09/22/2021
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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