EASY DIAGNOST ELEVA DRF *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-16 for EASY DIAGNOST ELEVA DRF * manufactured by Philips Medical Systems.

Event Text Entries

[4760245] The patient was prone on the fluoro table, crossed arms up (tucked under pillow) with the patient's head resting on the pillow. The fluoro table was moved back to the original position. The patient cried out in pain. The patient's skin on forearm was pinched between the table and the movable table top. The patient experienced an abrasion and bruising of the left forearm. The area was examined, cleaned and bandaged.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4100706
• MDR Report Key: 4100706
• Date Received: 2014-09-16
• Date of Report: 2014-09-16
• Date of Event: 2014-06-26
• Report Date: 2014-09-16
• Date Reported to FDA: 2014-09-16
• Date Reported to Mfgr: 2014-09-19
• Date Added to Maude: 2014-09-19
• 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: 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: EASY DIAGNOST ELEVA DRF
• Generic Name: TABLE, RADIOGRAPHIC, TILTING
• Product Code: IZZ
• Date Received: 2014-09-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Age: 7 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Manufacturer Address: 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-09-16