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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 Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2021
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 that the motor circuit breaker was tripping during the test on an aquabplus 1500 while in supply mode. The system was in emergency mode #2 when this occurred. There were no alarm codes displayed at the time of the failure. Upon further evaluation, the biomed noticed that one of the cable lugs on the motor protection switch was burnt. There was no burning smell, smoke, melting, or arcing noted, and there were no reports of sparks or flames. There was no damage to the cable itself; the biomed stated it was just the tip of the connector. No damage was identified on any other components. However, the biomed confirmed there was a blown fuse coming off of the surge protector in the local power supply. The biomed also confirmed there was a tripped thermal overload switch found in stage 1. To resolve the reported issue, the following parts were replaced: the thermal overload relay, the contactor 24v/25a, the connector cable motor protection switch, and the motor circuit breaker. The biomed stated the replaced parts were discarded; no parts were available for manufacturer evaluation. A photo of the damaged cable lug was provided in the initial reporting, and ftp machine files were provided for review. There were no known local power grid issues around the date of the event. There was no patient involvement associated with the reported event.
 
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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 Key11766370
MDR Text Key248706173
Report Number3010850471-2021-00010
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 company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2021
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 Received05/06/2021
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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