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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 Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/24/2018
Event Type  malfunction  
Event Description
It was reported that the device was over pressurizing.No patient injury was reported.Back-up device was available.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could not confirm the customer complaint for the device is over pressurizing.A visual inspection was performed and showed the upper and lower casing has scratches, the tube set holder paint coat is chipped, the front design is dented, and the hand wheel rubber tip is worn.Functional inspection was performed and the initial self-test passed, no errors occurred.Function testing was conducted and the pressure test and flow test were found to be in specifications.No manufacturing related defects were observed.
 
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Brand Name
PUMP A127 GOFLO
Type of Device
PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key7886106
MDR Text Key120702625
Report Number3003604053-2018-00149
Device Sequence Number1
Product Code FEQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72204968
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2018
Date Manufacturer Received10/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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