MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS, HF 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 04/19/2022

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 sustained thermal damage. There were no alarms. The aquabplus system was in standby mode at the time of the discovery. The biomed stated they were replacing the level rod (with float) because the disinfection cycle would not complete. Upon lifting the cover, a burnt wire connector was identified on the stage 1 power switch. This occurred after the clinic had closed for the day and there was no patient involvement. There was no evidence of any burning smell, smoke, sparks, or flames. The biomed stated there was nothing wrong with the machine, other than the fact that it would not complete the disinfection cycle. The thermal overload switch was not tripping, and there were no blown fuses in the local power supply. The biomed also confirmed there were no local power grid issues at the time of the event. After replacing the level rod, the machine was able to complete disinfection. The burnt wire connector was not replaced. The biomed was unable to provide the ftp files. The level rod that was replaced was available to be returned for evaluation.

• Brand Name: AQUABPLUS, HF 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14356722
• Report Number: 3010850471-2022-00010
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: G02040107-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/25/2022
• 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
• Patient Sex: No Answer Provided
• Patient Weight: KG