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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO RENTAL DEVICE
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SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO RENTAL DEVICE Back to Search Results
Model Number WD66800164R
Device Problems Device Alarm System (1012); No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2014
Event Type  malfunction  
Event Description
Screen not showing any information.Device will not alarm.
 
Event Description
Failure to alarm.Screen not showing any information.Device will not alarm.
 
Manufacturer Narrative
Active investigation in progress; results of investigation will be provided in a supplement report.
 
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Brand Name
RENASYS GO RENTAL DEVICE
Type of Device
RENASYS GO RENTAL 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 Key3921566
MDR Text Key5222197
Report Number3006760724-2014-00391
Device Sequence Number1
Product Code BTA
Combination Product (y/n)N
PMA/PMN Number
K083375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 07/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberWD66800164R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2014
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/11/2014
Date Manufacturer Received06/11/2014
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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