MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RENASYS GO NPWT DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 66800164

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

Electrical malfunction of the renasys go power supply.Customer stated that there were scorch marks on the lower left area on battery brick.She stated that the electrical malfunction melted some of the plastic.Event did not result in any harm or injury to the patient.

Manufacturer Narrative

This report is being submitted retrospectively due to the fact that information reviewed during the course of the investigation indicated the need to re-evaluate our original reportability assessment.Based on the information provided, the device did not cause or contribute to a death or serious injury, nor has it been implicated by the medical professional.However, the information provided does suggest that the device may have malfunctioned; and such a malfunction may have the potential to cause or contribute to a death or serious injury, if the malfunction were to recur.

• Brand Name: RENASYS GO NPWT DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• 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: 4200526
• MDR Text Key: 4965119
• Report Number: 3006760724-2014-00428
• 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: User Facility,Company Representative
• Type of Report: Initial
• Report Date: 04/04/2014

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: Other
• Device Model Number: 66800164
• Other Device ID Number: 03313
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1