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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.
 
Manufacturer Narrative
Additional information: h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.A review of the complaint history revealed that the reported event is a known problem.The reported event was confirmed based on provided photos.The reported error code ¿w-02-52-03: heat disinfection stopped¿ was found during review of the machine files.The error was triggered by a wdg failure of the cpu.The wdg failure is triggered when the internal cpu test routine fails.When a wdg failure occurs, the manufacturer highly recommends replacing the complete electronics (including the sd card).The heat damage identified at the power supply unit terminal connector was confirmed by reviewing the provided pictures.The reported issue was resolved by replacing the 24 volt dc connection cable.The device history record (dhr) review was performed.The review confirmed the device was released without any discrepancies and was found to be confirming to all specifications.The review of the instructions for use (ifu) reveals that the reported error code (w-02-52-03) is adequately addressed.A review of the service manual (sm) revealed that a visual inspectin of the aquabplus is part of the technical safety check.Based on the provided photos, the reported problem was able to be confirmed.The issue was resolved onsite by replacing the damaged cable.
 
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 Name
AQUABPLUS 1500
Type of Device
SUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
sailauf 63877
GM  63877
MDR Report Key11318637
MDR Text Key231533605
Report Number3010850471-2021-00005
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
PMA/PMN Number
K133829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was 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
Device AgeMO
Date Manufacturer Received02/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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