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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS EZ MAX; RENASYS EZ MAX, HOSPITAL
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SMITH & NEPHEW WOUND MANAGEMENT RENASYS EZ MAX; RENASYS EZ MAX, HOSPITAL Back to Search Results
Model Number 66801309
Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)
Patient Problem Fluid Discharge (2686)
Event Date 05/16/2014
Event Type  malfunction  
Event Description
Failure to alarm: "received call from (b)(6), (b)(6) 2014 that there was an issue with the pumps.I called the (b)(4) to meet with her.When i arrived, i can see that the soft port was contracted but the foam was not.There was pooling around the wound site and no alarms.".
 
Event Description
The soft port was contracted but the foam was not.There was pooling around the wound site and no alarms.
 
Manufacturer Narrative
Active investigation in progress; results of investigation will be submitted in a supplement report.
 
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Brand Name
RENASYS EZ MAX
Type of Device
RENASYS EZ MAX, HOSPITAL
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 Key3870229
MDR Text Key4458768
Report Number3006760724-2014-00385
Device Sequence Number1
Product Code BTA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132446
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 11/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number66801309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2014
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date05/16/2014
Date Manufacturer Received05/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Patient Sequence Number1
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