MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RENASYS GO RENTAL; NEGATIVE PRESSURE WOUND THERAPY SYSTEM

Model Number 66800164R

Device Problems Arcing (2583); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2015

Event Type  malfunction  

Event Description

Arcing sparks flew from the renasys go charger (point between cable and transformer) when hcp plugged into the wall.The charger was attached to the device, which was attached to the patient, when the event occurred.

• Brand Name: RENASYS GO RENTAL
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 970 lake carillon drive; st petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 970 lake carillon dr; st petersburg FL 33716
• Manufacturer Contact: claudia odoy ; schachenallee 29; SZ 5001 ; 0628320660
• MDR Report Key: 5301545
• MDR Text Key: 34281021
• Report Number: 3006760724-2015-00116
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

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
• Device Operator: Lay User/Patient
• Device Model Number: 66800164R
• Device Catalogue Number: 66800164R
• Device Lot Number: KGUB121675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention