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

Catalog Number G02040108-US

Device Problem Sparking (2595)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

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 2500 experienced blown 20 amp fuses, which led to the main breaker panel tripping. When the biomed turned on the motor protection switch, the back of the machine "sparked and zapped" to shut itself off. There was no visible thermal damage found. The 20 amp fuses were replaced with 25 amp fuses to resolve the issue. The 20 amp fuses were not available to be returned for evaluation, and no pictures could be provided. There was no report of patient involvement associated with the event.

• Brand Name: AQUABPLUS 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11255555
• MDR Text Key: 232364627
• Report Number: 3010850471-2021-00003
• 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: 03/04/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040108-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 02/12/2021
• 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