MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT E-Z CARE WOUND VACUUM SYSTEM; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800187

Device Problems Device Alarm System (1012); Suction Problem (2170)

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

Event Date 05/01/2012

Event Type  malfunction  

Event Description

Patient is on ez care and renasys soft port with an area of the dressing that is not compressed but dressing is seal, pump is not alarming and they changed the renasys soft port on top which seemed to resolve the uneven appearance of the dressing.

Manufacturer Narrative

The issue was not confirmed, as the device was not available for evaluation.The root cause of the reported issue cannot be determined.It is recommended that the device be returned for evaluation in order to rule out a pump malfunction, as cause of the reported issue.The ez care system is a legacy npwt system which has been replaced by the renasys line of negative pressure wound therapy.No further investigation and/or corrective actions will be taken at this time.If the unit is returned for evaluation or additional information is provided, smith & nephew will re-open and conduct additional evaluation and investigations as necessary.This medical device report (mdr) is being submitted by smith & nephew as a result of a retrospective review of complaints, including adverse events, as part of corrective and remediation actions following the issuance of the 483 issued november 26, 2013 to smith & nephew, inc.Fei no: (b)(4).Smith & nephew is performing a two-year retrospective review of complaint files to re-assess reportability criteria and reporting decisions made for complaints recorded during the time period under review.This complaint has been re-assessed in accordance under the provisions of 21cfr 803.50 and deemed reportable as an mdr.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the e-z care wound vacuum system.

• Brand Name: E-Z CARE WOUND VACUUM SYSTEM
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• 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: 3774103
• MDR Text Key: 20453416
• Report Number: 3006760724-2014-00337
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061919
• 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
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800187
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/10/2012
• Date Manufacturer Received: 05/10/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1