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

Model Number 66800164

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

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

Event Date 03/09/2014

Event Type  malfunction  

Event Description

Failure to alarm.Dressing would not collapse when connected.No alarm.Pump running fine when capped.

Manufacturer Narrative

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

Manufacturer Narrative

Upon evaluation of the returned device the complaint was confirmed.A technical evaluation of the pump conducted on 28 march 2014 confirmed the device failed functional testing (could not control pressure from front membrane).Cause of functional failure was a damaged front membrane.The exact root cause of the damaged front membrane cannot be firmly determined; however the most probable causes could be related to improper handling (device dropped/damaged during transit).As a corrective action membrane and top case were replaced; the repaired device passed all functional testing and was confirmed working within specifications (refer to service notification # (b)(4)).No further action is necessary; the information provided confirms there were no patient injuries or harm associated with this issue.The complaint is recorded and any similar issues will be monitored through the complaint system.

Event Description

Failure to alarm.Dressing would not collapse when connected.No alarm.Pump running fine when capped.

• Brand Name: RENASYS GO NPWT DEVICE
• Type of Device: RENASYS GO NPWT 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: 3860898
• MDR Text Key: 4659440
• Report Number: 3006760724-2014-00372
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/13/2014
• Event Location: Home
• Date Manufacturer Received: 03/13/2014
• 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 Age: 60 YR
• Patient Weight: 64