MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO RENTAL DEVICE

Model Number 66800164R

Device Problems Device Alarm System (1012); Leak/Splash (1354)

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

Event Date 06/24/2014

Event Type  malfunction  

Event Description

Failure to alarm.High volume (not picking up small seal leak).

Event Description

High volume; not picking up small seal leak.

Manufacturer Narrative

Active investigation in progress; results of investigation will be provided in a supplement report.

• Brand Name: RENASYS GO RENTAL DEVICE
• Type of Device: RENASYS GO RENTAL DEVICE
• 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: 3952669
• MDR Text Key: 4613478
• Report Number: 3006760724-2014-00397
• 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: Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800164R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/24/2014
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1