PUMP A127 GOFLO 72204968

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-17 for PUMP A127 GOFLO 72204968 manufactured by Smith & Nephew, Inc..

Event Text Entries

[111742992] Foreign zip code: (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[111742993] It was reported calibration issues have caused high flow. A backup device was available to complete the procedure with no delay or patient injuries.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003604053-2018-00091
• MDR Report Key: 7608474
• Date Received: 2018-06-17
• Date of Report: 2018-08-06
• Date of Event: 2018-06-06
• Date Mfgr Received: 2018-08-02
• Date Added to Maude: 2018-06-17
• 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: JIM GONZALES
• Manufacturer Street: 7000 WEST WILLIAM CANNON DRIVE
• 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: 2018-06-17
• Model Number: A127
• Catalog Number: 72204968
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: *
• 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		2018-06-17