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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RENASYS GO NPWT DEVICE
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SMITH & NEPHEW, INC. RENASYS GO NPWT DEVICE Back to Search Results
Catalog Number 66800164
Device Problems Thermal Decomposition of Device (1071); Material Discolored (1170); Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 04/15/2015
Event Type  malfunction  
Event Description
It was reported that while using the device, the orange power cable began to smoulder at the point of connection with the black power pack.There was physical blackening of the twin pronged connector of the orange cable and the staff reported smoke being produced.There was no patient involvement.A back-up device was available.
 
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Brand Name
RENASYS GO NPWT DEVICE
Type of Device
RENASYS GO NPWT DEVICE
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 Key4707665
MDR Text Key5723098
Report Number3006760724-2015-00040
Device Sequence Number1
Product Code OMP
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/01/2015
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 Health Professional
Device Catalogue Number66800164
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/15/2015
Initial Date FDA Received04/20/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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