MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS, HF 2500 SUBSYSTEM, WATER PURIFICATION

Catalog Number G02040108-US

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

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 that an aquabplus 2500 had no display and would not power on in the morning. The machine had been in standby mode prior to this failure occurring. There were no machine alarms to report. While inspecting the machine, the biomed identified blown fuses on the stage 1 power supply board. The biomed replaced two 3. 15a fuses from the power supply board. After doing so, when the motor protection switch (mps) was turned on, sparks were noticed coming from the power supply board. The biomed then tried switching the power supply from stage 2 to stage 1, but this did not resolve the issue. As a result, the power supply board from stage 1 was replaced. The biomed did not notice any visible burn damage on the power supply board. However, they did notice a burning smell. There was no evidence of any smoke or flames. It was confirmed that the thermal overload was not tripping. In addition, there were no local power grid issues at the time of the event. No patients were in treatment when this occurred, and therefore there was no patient injury or harm. The machine was confirmed to be fully operational at the time of follow-up. The ftp files were provided for review and the power supply board was reportedly available to be returned for evaluation.

• Brand Name: AQUABPLUS, HF 2500
• Type of Device: SUBSYSTEM, 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14188182
• MDR Text Key: 290528634
• Report Number: 3010850471-2022-00009
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133829
• Number of Events Reported: 1
• 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: 05/24/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: G02040108-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/04/2022
• 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