MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RENASYS GO NPWT DEVICE

Model Number 66800164

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

Though the customer replaced the canister and filler with new one, the device continued to show warning leak.The filler was compressed.

Event Description

Leak though the customer replaced the canister and filler with new one, the device continued to show ¿warning!! leak¿.The filler was compressed.

• Brand Name: RENASYS GO NPWT DEVICE
• Type of Device: RENASYS GO NPWT DEVICE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 4185867
• MDR Text Key: 5646035
• Report Number: 3006760724-2014-00420
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800164
• Other Device ID Number: KGUK120056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/25/2014
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1