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

Model Number	0874010
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2018
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 the motion negative pressure wound therapy device was smoking/overheating during 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.The patient was put on rescue dressing.

• Brand Name: INVIA MOTION+ ENDURE SINGL
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4; baar zug 6341, ; SZ
• MDR Report Key: 8223009
• Report Number: 1419937-2019-00003
• Device Sequence Number: 19360960
• Product Code: OMP
• UDI-Device Identifier: 07612367052849
• UDI-Public: 07612367052849
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0874010
• Device Catalogue Number: 0874010
• Device Lot Number: N/I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1