MAUDE Adverse Event Report: MEDELA AG INVIA MOTION+ 60 DAY SINGLE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 0874014

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problem No Information (3190)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

The device was requested for return and a replacement device was sent.An evaluation of the device on 02/09/2018 confirmed that this complaint is related to an issue identified on 01/19/2018 in which otherwise fully functioning pumps display a battery missing error notification, which can be caused by repetitive unplugging and plugging when the battery is fully charged.This situation can potentially lead to a therapy interruption.The user is notified of such malfunction via an audible and visual notification and is instructed via the instructions for use to contact their healthcare provider in order to receive a replacement device.

Event Description

On (b)(6) 2017, a distributor reported to medela (b)(4) that the motion+ pump was working properly with full battery and suddenly the alarm belled and the pump ran out of battery.They connected to power, but the screen was white and the battery symbol appeared full without suction.After waiting a while, the pump started to work again, but they noticed that the pump was very warm.

• Brand Name: INVIA MOTION+ 60 DAY SINGLE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar switzerland 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar kanton zug 6341 ; SZ 6341
• Manufacturer Contact: 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7305622
• MDR Text Key: 101603111
• Report Number: 1419937-2018-00063
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K161128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0874014
• Device Catalogue Number: 0874014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Distributor Facility Aware Date: 12/11/2017
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1