PUMP A127 GOFLO ED72204968 72204968

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-27 for PUMP A127 GOFLO ED72204968 72204968 manufactured by Smith & Nephew, Inc..

Event Text Entries

[87740234]
Patient Sequence No: 1, Text Type: N, H10

[87740235] It was reported that the device was not working. No patient injury or complications were reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003604053-2017-00094
• MDR Report Key: 6897225
• Date Received: 2017-09-27
• Date of Report: 2017-11-30
• Date of Event: 2017-09-12
• Date Mfgr Received: 2017-11-29
• Date Added to Maude: 2017-09-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR JIM GONZALES
• Manufacturer Street: 7000 W. WILLIAM CANNON DR.
• Manufacturer City: AUSTIN TX 78735
• Manufacturer Country: US
• Manufacturer Postal: 78735
• Manufacturer G1: SMITH & NEPHEW, INC.
• Manufacturer Street: 150 MINUTEMAN ROAD
• Manufacturer City: ANDOVER MA 01810
• Manufacturer Country: US
• Manufacturer Postal Code: 01810
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: PUMP A127 GOFLO
• Generic Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Product Code: FEQ
• Date Received: 2017-09-27
• Returned To Mfg: 2017-11-02
• Model Number: ED72204968
• Catalog Number: 72204968
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITH & NEPHEW, INC.
• Manufacturer Address: 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-09-27