MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 1000 SUBSYSTEM, WATER PURIFICATION

Catalog Number G02040103-US

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.

Event Description

An area technical operations manager (atom) reported that an aquabplus 1000 sustained thermal damage during heat disinfect. The system was running in heat disinfect, and before concluding, it had to be manually put into cool-down. The atom stated there must have been some sort of interruption, but it was unknown if there were alarms. Approximately ten minutes later, the screen went blank, and the system powered down. The machine would not power back on after this. During troubleshooting, it was discovered that the power switch had overheated. There was a burning smell noted, and charring/thermal damage was present on the wiring and spade connectors on the back side of the motor protection switch. There was no evidence of any smoke, sparks, or flames. The atom confirmed the thermal overload switch was not tripping, and there were no local power grid issues in the area on the event date. In addition to the thermal damage at the motor protection switch, a blown 25 amp fuse was found in the local power supply. To resolve the reported issue, the motor protection switch was replaced along with the blown fuse. New wiring was also ordered and will be replaced when received. The atom confirmed the motor protection switch was available to be returned for evaluation. Photos of the thermal damage were provided for review, and the ftp files were as well. There was no patient involvement associated with the reported event.

• Brand Name: AQUABPLUS 1000
• 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: 12447452
• MDR Text Key: 270558583
• Report Number: 3010850471-2021-00023
• 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,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040103-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: 10/13/2021
• 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