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

Model Number 66800164R

Device Problems Leak/Splash (1354); Sparking (2595)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

Sparks flew from the renasys go charger, believed to have been caused by a pump leak for which there was no leak alarm.

• Brand Name: RENASYS GO
• 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 drive; st petersburg FL 33716
• Manufacturer Contact: claudia odoy ; schchenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 5302349
• MDR Text Key: 34326806
• Report Number: 3006760724-2015-00119
• 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: Other
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2016
• 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): Other