MODALITY POLYGRAPH SYSTEM * POS-81020C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-27 for MODALITY POLYGRAPH SYSTEM * POS-81020C manufactured by Synectics Medical, Inc..

Event Text Entries

[106953] Pt given sedation while biliary motility machine was being calibrated. Unable to calibrate machine. Ercp procedure cancelled due to machine not functioning. Voluntary report file.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1013064
• MDR Report Key: 152928
• Date Received: 1998-02-27
• Date of Report: 1998-02-13
• Date of Event: 1998-02-05
• Date Added to Maude: 1998-03-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MODALITY POLYGRAPH SYSTEM
• Generic Name: BILIARY MOTILITY MACHINE
• Product Code: FES
• Date Received: 1998-02-27
• Model Number: *
• Catalog Number: POS-81020C
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 148990
• Manufacturer: SYNECTICS MEDICAL, INC.
• Manufacturer Address: 1425 GREEWAY DR. SUITE 600 IRVING TX 75038 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1998-02-27