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

Model Number	0874010
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempts were made to obtain the motion device for evaluation; however, the customer indicated that the pump was received at their distribution center on 09/13/2019 and was destroyed.On (b)(6) 2019, a medela rn consulted with a customer representative who had spoken with the patient.The patient did have debridement, although debridement is standard of practice for a chronic wound.Based on the consultation, the medela rn determined that the nurse performed efficient and correct troubleshooting of the device.Though a root cause for the leak in the dressing is unknown, patient error/non-compliance may have been a contributing factor.It is not certain that proper assessment of the dressing by the patient occurred.The customer representative indicated that four (4) different vna nurses had dressed the wound and the last dressing application was bridged to the bottom of the foot, which could have contributed to the exudate pooling under the dressing.At this time, the wound is progressing well and showing signs of healing.
Event or Problem Description
On (b)(6) 2019, a customer alleged to medela llc that the motion device was not signaling or beeping to inform of a leak while in use on a patient, who was being treated with negative pressure wound therapy following a toe amputation.The customer further alleged that the drape held the leakage in so the patient was in a wet dressing for two days awaiting his next doctor's visit, which resulted in an infection.The doctor had to debride into the ball of the patient's foot and, in doing so, the wound became much deeper/larger.The patient was switched to a liberty device because there was too much drainage for the motion.

• Brand Name: INVIA MOTION+ ENDURE SINGLE
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): MEDEDLA AG; lattichstrasse 4b; baar zug 6341, ; SZ
• MDR Report Key: 9219009
• Report Number: 1419937-2019-00138
• Device Sequence Number: 16844527
• 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,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0874010
• Device Catalogue Number: 0874010
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other