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 No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2012

Event Type  malfunction  

Event Description

Failure to alarm: patient said that the suction seemed to have reduced however the pump did not alarm.The exudate was not moving down the tube at all.

Manufacturer Narrative

The issue was not confirmed.The probably root cause could be due to battery issues, software errors, mechanical or component failure.As evidenced by the serial number the age of the device is more than 2 years old; at this time the internal pump maybe is reaching the end of the life cycle.In order to rule out the root cause of the problem the console is needed for evaluation.A definitive root cause could not be determined at this time without the unit.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: 3765980
• MDR Text Key: 4552745
• Report Number: 3006760724-2014-00288
• Device Sequence Number: 1
• Product Code: BTA
• 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: 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: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800164
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/10/2012
• Event Location: Hospital
• Date Manufacturer Received: 04/10/2012
• 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