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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RENASYS GO NPWT DEVICE; RENASYS GO V2
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SMITH & NEPHEW, INC. RENASYS GO NPWT DEVICE; RENASYS GO V2 Back to Search Results
Model Number 66800164
Device Problems Sparking (2595); Electrical Shorting (2926)
Patient Problem No Information (3190)
Event Date 01/21/2015
Event Type  malfunction  
Event Description
When trying to establish a connection to the power supply, this resulted in a short circuit with sparks.Nobody was harmed by this issue.
 
Manufacturer Narrative
 
Event Description
When trying to establish a connection to the power supply, this resulted in a short circuit with sparks.Nobody was harmed by this issue.
 
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Brand Name
RENASYS GO NPWT DEVICE
Type of Device
RENASYS GO V2
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 Key4452549
MDR Text Key5395505
Report Number3006760724-2015-00005
Device Sequence Number1
Product Code OMP
Combination Product (y/n)N
PMA/PMN Number
K083375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/14/2015
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 Other
Device Model Number66800164
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/22/2015
Initial Date FDA Received01/26/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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