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U.S. Department of Health and Human Services

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

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VIVONIC GMBH AQUABPLUS, HF 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 05/11/2022
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 finding thermal damage on the power supply board from stage 1 of an aquabplus 1500. Initially, it was reported that the reverse osmosis (ro) system had no display. The failure occurred in the morning, before the clinic had opened. There was no patient involvement. During troubleshooting, the biomed found a blown 3. 15a fuse on stage 1. Upon further evaluation, the biomed noticed a mild burning smell and identified burn marks (or charring) on the power supply board from stage 1. The biomed also stated that the thermal overload switch was tripping on stage 1. To resolve the reported issue, they moved the power supply board from stage 2 to stage 1, and replaced the blown fuse. The biomed stated there were no issues with the stage 2 power supply board (no discolorations or burn damage). Upon follow-up, the biomed was waiting on a new power supply board to replace the damaged one. Per the biomed, there was a thunderstorm the night before the event. However, it was unknown if the clinic¿s electrical power was impacted from the storm. The biomed didn¿t think that the power surge protector was triggered because the light wasn¿t engaged in the morning. It was confirmed there were no blown fuses in the local power supply. According to the biomed, there were two alarm messages that occurred: ¿w-04-50-11 cleaning¿ and ¿warning t1 test valve v10 defective¿. There was no evidence of any smoke, sparks, or flames. The biomed provided photos of the damaged power supply board, as well as the machine files. The damaged board was available to be returned for evaluation.
 
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Brand NameAQUABPLUS, HF 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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14583668
MDR Text Key293246542
Report Number3010850471-2022-00013
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 07/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02040105-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received06/14/2022
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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