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

Catalog Number G02040108-US

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

A plant investigation is in progress.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A user facility biomedical technician (biomed) reported that an aquabplus reverse osmosis machine would not power back on after the power supply shut down.The machine was evaluated at the user facility by the biomed and the connection line 24v and the diode on the interlock relay were found to have burn damage.There was no report of any other heat or burn damage to the machine¿s components.No parts have been made available to be returned to the manufacturer for evaluation.No further information has been made available at this time.

Manufacturer Narrative

The reported complaint is not confirmed as the complaint device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by an employee of the manufacturer vivonic (b)(4).The manufacturer reviewed the details of the complaint, including photographs that were provided by the customer.It was reported that while the customer was troubleshooting the power supply failure, a burnt diode of the interlock relay and a burnt 24v connection line were both discovered by the biomedical technician (biomed).Based on the photograph provided by the customer, vivonic suggests that a suboptimal crimp connection contributed to an increase in resistance and temperature that resulted in the charred 24v connection line.The burnt diode of the interlock relay is alleged to have been caused by an incorrect wiring failure which was attributed to the facility technician.However, no parts or device were returned to the manufacturer for investigation.Therefore, the event remains unconfirmed.

Event Description

A user facility biomedical technician (biomed) reported that an aquabplus reverse osmosis machine would not power back on after the power supply shut down.The machine was evaluated at the user facility by the biomed and the connection line 24v and the diode on the interlock relay were found to have burn damage.There was no report of any other heat or burn damage to the machine¿s components.No parts have been made available to be returned to the manufacturer for evaluation.No further information has been made available at this time.

• 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: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6916909
• MDR Text Key: 89483261
• Report Number: 3010850471-2017-00001
• 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,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Catalogue Number: G02040108-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 11/16/2017
• Supplement Dates FDA Received: 12/12/2017
• 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 Sequence Number: 1