MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RENASYS GO POWER SUPPLY

Model Number 66800161

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 09/29/2014

Event Type  malfunction  

Event Description

Cable connector issue the transformer burned the primary level (cable 220v female / connector male transformer).

Event Description

Cable connector issue the transformer burned the primary level (cable 220v female / connector male transformer).

• Brand Name: RENASYS GO POWER SUPPLY
• Type of Device: RENASYS GO POWER SUPPLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 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: 4189754
• MDR Text Key: 5346207
• Report Number: 3006760724-2014-00422
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• 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: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800161
• Device Lot Number: LA 029448
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 10/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1