PHILLIPS SIEMENS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-13 for PHILLIPS SIEMENS * manufactured by Phillips Medical Systems.

Event Text Entries

[181685] Lead shield (glass) separated from arm and fell. Grazed pt - no skin tear or bruising. Possible fracture to physician's arm. Minimum welding noted at same site on other arm. Occurred in cath lab. The shield separated from the device and fell on a physician's arm, causing a hairline fracture. It grazed the pt, but caused no injury to the pt. Cath lab personnel notified the co immediately, and hosp maintenance dept made the necessary repair. The incident occurred 8/14/00, however risk mgmt was not made aware until 9/8/00, at which time a report was completed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	296360
MDR Report Key	296360
Date Received	2000-09-13
Date of Report	2000-09-08
Date of Event	2000-08-14
Date Facility Aware	2000-09-08
Report Date	2000-09-08
Date Reported to FDA	2000-09-11
Date Reported to Mfgr	2000-09-11
Date Added to Maude	2000-09-19
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	0
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	PHILLIPS SIEMENS
Generic Name	LEAD GLASS SHILED ON ARM
Product Code	IWQ
Date Received	2000-09-13
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	286858
Manufacturer	PHILLIPS MEDICAL SYSTEMS
Manufacturer Address	710 BRIDGEPORT AVE SHELTON CT 06484 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-09-13