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 05/29/2017

Event Type  malfunction  

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. The facility biomedical technician discovered a burnt connector at the 24v power supply unit. The general function of the device was not impacted by the damage to this specific component. Based on the photograph provided by the customer, vivonic states that the component was likely burnt due to a suboptimal crimp contact. The crimp contact caused an increase in electrical resistance which resulted in the heating and burning of the connector plastic. However, as the actual device was not returned to the manufacturer for investigation and there was no on-site service provided, the event remains unconfirmed.

Event Description

A user facility biomedical technician (biomed) reported that an aquabplus reverse osmosis machine and the connection line 24v was 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

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 and the connection line 24v was 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: 6917064
• MDR Text Key: 251885922
• Report Number: 3010850471-2017-00002
• 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

0 Patients were Involved in the Event:

• Date FDA Received: 10/05/2017
• 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

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 11/16/2017
• 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