MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS EZ MAX, HOSPITAL

Model Number 66801309

Device Problem Device Alarm System (1012)

Patient Problem Fluid Discharge (2686)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

There was pooling around the wound side and no alarms.

Manufacturer Narrative

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

Event Description

There was pooling around the wound side and no alarms.

• Brand Name: RENASYS EZ MAX, HOSPITAL
• Type of Device: RENASYS EZ MAX, HOSPITAL
• 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: 3870473
• MDR Text Key: 4564439
• Report Number: 3006760724-2014-00386
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• PMA/PMN Number: K132446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66801309
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/21/2014
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other