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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. PUMP A127 GOFLO PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE Back to Search Results
Catalog Number 72204968
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/26/2017
Event Type  malfunction  
Manufacturer Narrative
An evaluation was performed by the supplier and could not confirm the customer complaint for the goflo pump had an overflowed joint. A visual inspection was performed and showed the tube set holder to be chipped, the lower casing is cracked, the upper casing has a big dent around the area of the power entry module, and the roller wheel is slightly pushed in. Functional inspection indicated the device passed all criteria. This included a flow test, pressure test, and rpm test with a result of pass. The pump was tested several times with water, set pressure was increased and decreased multiple times and it was clearly seen that the flow clearly increased and decreased. No functional problems were found. Device evaluated by the manufacturer.
 
Event Description
It was reporting that the goflo pump had an overflowed joint. The procedure was completed with another method. The procedure was completed with another method. No patient injuries reported.
 
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Brand NamePUMP A127 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 dr.
austin, TX 78735
MDR Report Key7225753
MDR Text Key264926942
Report Number3003604053-2018-00017
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72204968
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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