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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL {} A127 PUMP GOFLO PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

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SMITH & NEPHEW, INC. SVCE REPL {} A127 PUMP GOFLO PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE Back to Search Results
Catalog Number 72204968S
Device Problems Excess Flow or Over-Infusion (1311); Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2018
Event Type  malfunction  
Event Description
It was reported that the device is not working properly, not calibrating. The pump seemingly overpresurize and have excessive flow. The procedure was completed with the same device, no significant delay and no patient injuries.
 
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Brand NameSVCE REPL {} A127 PUMP GOFLO
Type of DevicePUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key7834079
MDR Text Key118875526
Report Number3003604053-2018-00135
Device Sequence Number1
Product Code FEQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72204968S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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