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

Model Number 66800164

Device Problem Device Inoperable (1663)

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

Event Date 01/28/2016

Event Type  malfunction  

Event Description

A report of device failure has been received.Suction failure has been stated.

• 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 dr; st petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 970 lake carillon dr; st petersburg FL 33716
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 5462798
• MDR Text Key: 39478806
• Report Number: 3006760724-2016-00019
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 02/16/2016

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: No Information
• Device Model Number: 66800164
• Device Catalogue Number: 66800164
• Device Lot Number: KGVG130314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2016
• 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: N
• Patient Sequence Number: 1