MAUDE Adverse Event Report: MEDELA AG INVIA MOTION+ 15 DAYS SINGLE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 0874012

Device Problems Nonstandard Device (1420); Aborted Charge (2288); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2018

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 invia motion negative pressure wound therapy device was getting hot and was not fully charging 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+ 15 DAYS 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: 8560058
• MDR Text Key: 144004501
• Report Number: 1419937-2019-00069
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 07612367053167
• UDI-Public: 07612367053167
• 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: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0874012
• Device Catalogue Number: 0874012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2018
• Date Manufacturer Received: 04/23/2019
• 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