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

Model Number 0874010

Device Problems Nonstandard Device (1420); Overheating of Device (1437); Loss of Power (1475)

Patient Problem Wound Dehiscence (1154)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

The device was requested for return and a replacement device was sent to the customer.An evaluation of the device confirmed that this complaint is related to an issue 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 a 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, the customer alleged to medela llc that the motion negative pressure wound therapy device overheats and occasionally shuts down while on a patient; though, there was no serious injury, the patient did not experience wound deterioration and the patient did not require consultation and/or treatment by a medical professional.

• Brand Name: INVIA MOTION+ ENDURE SINGLE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 8257167
• MDR Text Key: 134876137
• Report Number: 1419937-2019-00012
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 07612367052849
• UDI-Public: 07612367052849
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0874010
• Device Catalogue Number: 0874010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1