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

Catalog Number G02040105-US

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 04/12/2021

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 the motor circuit breaker was tripping during the test on an aquabplus 1500 while in supply mode. The system was in emergency mode #2 when this occurred. There were no alarm codes displayed at the time of the failure. Upon further evaluation, the biomed noticed that one of the cable lugs on the motor protection switch was burnt. There was no burning smell, smoke, melting, or arcing noted, and there were no reports of sparks or flames. There was no damage to the cable itself; the biomed stated it was just the tip of the connector. No damage was identified on any other components. However, the biomed confirmed there was a blown fuse coming off of the surge protector in the local power supply. The biomed also confirmed there was a tripped thermal overload switch found in stage 1. To resolve the reported issue, the following parts were replaced: the thermal overload relay, the contactor 24v/25a, the connector cable motor protection switch, and the motor circuit breaker. The biomed stated the replaced parts were discarded; no parts were available for manufacturer evaluation. A photo of the damaged cable lug was provided in the initial reporting, and ftp machine files were provided for review. There were no known local power grid issues around the date of the event. There was no patient involvement associated with the reported event.

• Brand Name: AQUABPLUS 1500
• 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: 11766370
• MDR Text Key: 248706173
• Report Number: 3010850471-2021-00010
• 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: 05/28/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040105-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: 05/06/2021
• 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