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

Model Number	0874010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2018, the customer alleged to medela llc that when the motion negative pressure would therapy device was not plugged into an electrical outlet, it powered down and would not power back on, though approximately 30 minutes later it powered on without prompting.Though the issue occurred while on a patient, 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
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341, switzerland
• MDR Report Key: 8491395
• Report Number: 1419937-2019-00059
• Device Sequence Number: 11038881
• Product Code: OMP
• UDI-Device Identifier: 07612367052849
• UDI-Public: 07612367052849
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0874010
• Device Catalogue Number: 0874010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/08/2019
• Patient Sequence Number: 1