MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT VERSAJET II CONSOLE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800039

Device Problems Failure to Power Up (1476); Electrical Shorting (2926)

Patient Problem No Code Available (3191)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

No power.Machine would not get power.Changed plugs in room would not work, pushed button would not work, put handpiece in took out tried again, no power.Biomed changed fuse, blow as soon as new was put in.They did not even get to use it.Procedure delayed 30 minutes while patient under anesthesia.Alternate therapy used (hand debridement).

Manufacturer Narrative

Smith & nephew was made aware of additional information on 07/09/2014 which based upon recent re-assessment, we believe re-classifies this event as a reportable malfunction as per 21 cfr part 803 of the medical device reporting regulation.The additional information received indicates the device malfunction (power failure) occurred in the or while the patient was under anesthesia and resulted in a 30 minute delay and the use of an alternate therapy (hand debridement).The reported complaint was deemed confirmed during evaluation of the returned device.The most probable root cause for the issue was determined to be a faulty power supply.The defective power supply was returned to the vendor for analysis.Corrective action was initiated to investigate electrical issues for the versajet ii consoles.Modifications to improve the performance of the power supply have been implemented.No further corrective action will be taken at this time.Future product complaints will continue to be tracked and trended to detect any recurring issues and if needed, additional corrective action(s) will be initiated at that time.Based on information provided, the reported event did not result in patient injury or adverse event.

• Brand Name: VERSAJET II CONSOLE
• 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: 3947941
• MDR Text Key: 15358797
• Report Number: 3006760724-2014-00394
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2014
• Distributor Facility Aware Date: 05/28/2014
• Date Manufacturer Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1