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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 Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
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 an aquabplus 1500 stopped during heat disinfection, twice. The machine alarmed with the following alarm code: "w-02-52-03". The biomed was unable to duplicate the reported issue. While troubleshooting, the biomed discovered a discolored cable and reported that it exhibited evidence of possible heat damage. During additional follow-up, the biomed stated that the cable looked charred. The biomed was unsure if the damaged cable was related to the original issue. No damage was identified on any other machine components. The biomed confirmed there was no burning smell or melting noted, nor was there evidence of any smoke, sparks, or flames. The discolored/charred cable was replaced with a new one, and this resolved the reported issue. Subsequently, the biomed stated the machine was put through heat disinfection without any hold-ups. The biomed stated the cable would be returned to the manufacturer for evaluation. Photos of the cable were provided in the initial reporting. It was confirmed there was no patient involvement associated with the reported issue.
 
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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 Key11318637
MDR Text Key231533605
Report Number3010850471-2021-00005
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 03/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2021
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received02/23/2021
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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