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 12/02/2019

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's biomedical technician reported an aquab plus 2000 device had a p1s failure, the 24v power supply burned out and 2 fuses in the power disconnect box were burnt out.The area technical operations manager (atom) stated that the fuses were burned and a burning smell was observed.There was no smoke, flame, spark, arcing, or other visible damage related to the burned fuses in the power disconnect board.A picture of the power disconnect board was provided, which showed the burned fuses.The atom stated that the issue was discovered when they were moving into the facility, and there was no patient involvement.The fuses, the motor circuit breaker, the 24v power supply, and the motor contactor were replaced to resolve the issue.The type of fuse replaced was unknown.The device was returned to service.The parts were returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: concomitant medical products, device evaluated by mfr: plant investigation: review of the available machine files reveals that the reported error code could be seen for the reported event date.The error code is triggered during the t1-test when the pump p1s should start and the pressure p-cs must rise.This behavior could be seen in the available operation data.The reported event could be confirmed.The device history record related documentation has been reviewed.The device has been found to be conforming to the specifications and has been released without any discrepancies.The reported event could be seen during the investigation of the returned sample and in the provided picture.A reproduction is not necessary.The investigation of the returned components revealed measurement of the contact resistance.In off position the resistance is high (8o) and in the on position the resistance is zero (0o).No failure could be found.The motor protection switch measurement of the contact resistance, in off position the resistance is high (8o) and in the on position the resistance is zero (0o).No failure could be found.24vdc power supply, the high voltage side (120vac) shows overvoltage damages.Therefore, some components of the power supply are damaged.This kind of damage is most likely cause by overvoltage peaks from the power grid.The reported event could be confirmed by the damaged power supply.The review of the instructions for use reveals that the reported error code is adequately addressed.A falsification or unauthorized configuration can be excluded.Issues like lightning storms could not be confirmed by the biomedical technician for the event date.But the technician confirmed that they had a lot of construction next door to the facility.

• Brand Name: AQUABPLUS 2000
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• MDR Report Key: 9780858
• MDR Text Key: 181796354
• Report Number: 3010850471-2020-00003
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• PMA/PMN Number: K133829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040107-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Device Age: MO
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1