MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED); RENASYS EZ PLUS

Model Number 66800697

Device Problem Device Alarm System (1012)

Patient Problem Impaired Healing (2378)

Event Date 05/07/2014

Event Type  malfunction  

Event Description

Failure to alarm non-healing groin wound that is not improving most likely because the vacs used in hospital do not alarm when the seal goes off.

Event Description

Non-healing groin wound that is not improving; vacuum used in hospital do not alarm when the seal goes off.

Manufacturer Narrative

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

Manufacturer Narrative

No additional information received as of today.

• Brand Name: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Type of Device: RENASYS EZ PLUS
• 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 ; 7273993785
• MDR Report Key: 3888719
• MDR Text Key: 4545375
• Report Number: 3006760724-2014-00387
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2014,12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 66800697
• Device Catalogue Number: 66800697
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Report Sent to FDA: 06/23/2014
• Distributor Facility Aware Date: 05/30/2014
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1