MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO NEGATIVE PRESSURE WOUND THERAPY; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800164

Device Problem Device Alarm System (1012)

Patient Problem Fluid Discharge (2686)

Event Date 03/22/2012

Event Type  malfunction  

Event Description

Failure to alarm: system is not giving any alarm, although much is exsudate is under dressing.

Manufacturer Narrative

We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the renasys go negative pressure wound therapy.The issue was not confirmed.The root cause of the reported issue cannot be determined.It is recommended that the device be returned for evaluation in order to rule out a pump malfunction, as cause of the reported issue.Smith & nephew has issued (b)(4) to initiate renasys product labeling updates.These labeling updates will provide enhanced information on the functionality of the alarms as they relate to the design of the device, and scenarios that can occur in clinical settings which may impact alarm functionality.

• Brand Name: RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW WOUND MANAGEMENT; 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: 3764432
• MDR Text Key: 4547005
• Report Number: 3006760724-2014-00252
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800164
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/22/2012
• Event Location: Hospital
• Date Manufacturer Received: 03/22/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other