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 Patient Involvement (2645)

Event Date 12/12/2020

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 had no power to the stage 1 display. The biomed checked the fuses and found burnt cables at the motor protection switch, along with charring on the motor protection switch itself. The biomed resolved the reported issue by replacing the motor protection switch and the cables from the stage 1. After doing so, the biomed put the system into emergency bypass stage 1. No thermal damage was identified on any other machine components. There was no patient involvement associated with the reported issue. The samples were retained and the biomed stated they would be returned to the manufacturer for evaluation. In addition, a photo of the damaged components was provided.

• 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: 11114793
• MDR Text Key: 225028735
• Report Number: 1225714-2021-00001
• 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: 02/10/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/04/2021
• 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: 01/21/2021
• 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