ADAC VERTEX V60 EPIC-HP VRTXP *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-03 for ADAC VERTEX V60 EPIC-HP VRTXP * manufactured by Adac/philips Medical Systems.

Event Text Entries

[338173] Pt fell off the nuclear medicine table, while attempting to reposition with the assistance of the technician. Pt sustained a fractured left hip and right humerus.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 528883
• MDR Report Key: 528883
• Date Received: 2004-06-03
• Date of Report: 2004-06-03
• Date of Event: 2004-05-14
• Date Facility Aware: 2004-05-14
• Report Date: 2004-06-03
• Date Reported to FDA: 2004-06-03
• Date Reported to Mfgr: 2004-06-03
• Date Added to Maude: 2004-06-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ADAC VERTEX V60 EPIC-HP
• Generic Name: NUCLEAR MEDICINE UNIT
• Product Code: JAI
• Date Received: 2004-06-03
• Model Number: VRTXP
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 3 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 518071
• Manufacturer: ADAC/PHILIPS MEDICAL SYSTEMS
• Manufacturer Address: * BOTHELL WA 98041 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2004-06-03