MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2000 SUBSYSTEM, WATER PURIFICATION

Catalog Number G02040107-US

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 06/05/2021

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 2000 would not power on. The local staff had indicated there was a power disruption of unknown cause and the facilitys generator kicked in. The generator reportedly gave a power surge to the system, causing the 24 v power supply unit on stage 1 to fail. The power supply failure then caused the (3. 15 a) fuse that feeds it to blow. They determined this because the fuse was replaced before the power supply, and the fuse blew again. Upon further inspection it was noted that the cable, which connects from the motor protection switch (mps) to the power contactor, was burnt. The 24 v supply was taken from the side and placed on the side. This allowed the system to operate normally. The facility ordered a new 24 v supply, and the cable that feeds the motor protection switch (mps). There were no corresponding alarm codes that occurred during the failure. There was no report of smoke, and there was nobody in the water room at the time of the event to notice any sparks. The failure did not occur while patients were undergoing treatment, and therefore, there was no patient involvement. Once the replacement parts arrive, the 24 v supply from the primary stage will be returned for evaluation. A sample is expected to be sent back.

• Brand Name: AQUABPLUS 2000
• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12021968
• MDR Text Key: 257107596
• Report Number: 3010850471-2021-00017
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040107-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 07/06/2021
• 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