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

Model Number 0874014

Device Problems Failure to Charge (1085); Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

The device was exchanged and disposed of by the distributor.The defective device is not present for investigation.It was determined 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) 2018, a distributor reported to medela (b)(4) that the motion+ device cannot be charged anymore and turns off when it is disconnected from the power supply.When connected to the power supply, a blinking arrow shows on the display.

• 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: 7305626
• MDR Text Key: 101596785
• Report Number: 1419937-2018-00065
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: 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?: No
• Distributor Facility Aware Date: 01/18/2018
• Date Manufacturer Received: 01/19/2018
• Type of Device Usage: N
• Patient Sequence Number: 1