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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO RENTAL DEVICE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
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SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO RENTAL DEVICE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) Back to Search Results
Model Number 66800164R
Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2014
Event Type  malfunction  
Event Description
Failure to alarm.Black foam was not collapsed into the wound bed.No obvious leak and no alarm sounded.Dressing well secured and softport tubing appeared collapsed but not foam in wound bed.Dressing removed and pump did not alarm.Softport removed and pump did alarm after 5 mins.Obvious issue with dressing technique.Pump turned off and on but still no alarm.Overnight pump was flashing orange but no audible alarm sounding.
 
Manufacturer Narrative
Active investigation in progress; results of investigation will be provided in a supplement report.
 
Event Description
Failure to alarm.Black foam was not collapsed into the wound bed.No obvious leak and no alarm sounded.Dressing well secured and softport tubing appeared collapsed but not foam in wound bed.Dressing removed and pump did not alarm.Softport removed and pump did alarm after 5 mins.Obvious issue with dressing technique.Pump turned off and on but still no alarm.Overnight pump was flashing orange but no audible alarm sounding.
 
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Brand Name
RENASYS GO RENTAL DEVICE
Type of Device
PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
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 Key3865355
MDR Text Key4460704
Report Number3006760724-2014-00381
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,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number66800164R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2014
Is the Reporter a Health Professional? No
Distributor Facility Aware Date05/14/2014
Date Manufacturer Received05/14/2014
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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