PHILLIPS DIAGNOST 76+ *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-09-10 for PHILLIPS DIAGNOST 76+ * manufactured by Philips Medical Systems North America Co..

Event Text Entries

[121997] Pt on x-ray table to start endoscopic retrograde cholangio-pancreatography. Table would not stop. Left 4th finger caught in x-ray table, resulting in laceration and fracture. Pt taken to surgery for displaced fracture to left 4th finger.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW4002333
MDR Report Key	187595
Date Received	1998-09-10
Date of Report	1998-09-10
Date of Event	1998-09-10
Date Added to Maude	1998-09-18
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
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	PHILLIPS
Generic Name	FLUORO X-RAY UNIT
Product Code	IXL
Date Received	1998-09-10
Model Number	DIAGNOST 76+
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	182335
Manufacturer	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
Manufacturer Address	710 BRIDGEPORT AVE. SHELTON CT 06484 US
Baseline Brand Name	DIAGNOST 76 PLUS
Baseline Generic Name	GENERAL PURPOSE R/F SYSTEM (SPOT FILM/IMAGE INTENSIFIED)
Baseline Model No	9848-500-16202
Baseline Catalog No	NA
Baseline ID	NA
Baseline Device Family	DIAGNOST 76 FAMILY
Baseline Shelf Life [Months]	NA
Baseline PMA Flag	N
Baseline 510K PMN	Y
Premarket Notification	K924593
Baseline Preamendment	N
Baseline Transitional	N
510k Exempt	N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-09-10