SCP-80 MODEL SCP-80, RELEASE 6.3 KN188995

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-19 for SCP-80 MODEL SCP-80, RELEASE 6.3 KN188995 manufactured by Philips Medical Systems.

Event Text Entries

[404834] A bariatric patient was undergoing fluoroscopy examination. After 56 seconds of fluoroscopy, the examination technique was change because of poor quality to digital spot films. After a total of 39 digital spot films were completed, the x-ray tube exploded spraying the patient, x-ray technician and physician with oil. No injuries were reported. When removing the defective tube, both high tension cable candles were tight and required more than the usual force to remove. Close inspection showed identical cracks around the anode and cathode candles. The cracks traveled the complete circumference of the candle approximately 3/8 inch from the flange end. Biomedical department found the generator configuration setting 'no tube overload protection' set to on. After numerous communications with philips in germany, the correct firmware and software configurations were obtained. Philips provided the appropriate procedure for checkout of the device. Biomed performed the exposure part of tube overload protection procedure, in 'simulation mode. ' the test passed with 7 exposures. The fluoroscopy portion of the test also passed. Wait time came on at exactly 150 seconds. Philips/dunlee sales manager and product support engineer arrived. Tube housing safety switch operation was found to operating correctly when checked with an ohm meter. Sample of insulating oil from the defective tuber were gathered. X-ray tube taken to office for evaluation. The overload protection feature was not turned on which allowed the anode in the x-ray tube to overheat beyond its design limits and catastrophically fail.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 642598
• MDR Report Key: 642598
• Date Received: 2005-10-19
• Date of Report: 2005-09-19
• Date of Event: 2005-04-11
• Report Date: 2005-09-19
• Date Reported to FDA: 2005-10-19
• Date Added to Maude: 2005-10-26
• 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
• 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: SCP-80
• Generic Name: X-RAY EQUIPMENT
• Product Code: IXL
• Date Received: 2005-10-19
• Model Number: MODEL SCP-80, RELEASE 6.3
• Catalog Number: KN188995
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 632122
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Manufacturer Address: 3000 MINUTEMAN RD ANDOVER MA 018101099 US
• Baseline Brand Name: SCOPO 76
• Baseline Generic Name: SPOT FILM DEVICE
• Baseline Model No: 4512-129-06371
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: NA
• 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		2005-10-19