NI 9806-300-71202 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-07 for NI 9806-300-71202 NA manufactured by Philips Medical Systems North America, Inc..

Event Text Entries

[191782] A procedure was being performed, for a pt, when the power to the x-ray equipment failed. The table drifted back to about a 20-30% angle and stopped. The tower began drifting downward, which required that the attending radiologist to manually support the weight of the tower to keep the tower from lowering onto the pt. All equipment controls were unresponsive. The pt was moved from the x-ray table. No injuries were reported, to the pt or staff. Rptr talked with the tech and learned that the malfunction actually could have created an injury had the radiologist not supported the weight of the tower until the pt was moved from the x-ray table. When the repair tech arrived, rptr spoke extensively with them in an attempt to learn about the mechanism that controls the tower. From the conversation, it appears that the fail-safe mechanism did not function properly. Also, if the table was in the flat position, the tower could drop to about six inches above the table, which would place the tower onto a pt. The repair tech did mention that this particular problem, referred above, should not have occurred based upon safeguards incorporated into the equipment. The equipment was repaired and placed back into svc. Rptr questions: why the fail-safe mechanism did not function properly and could this particular problem occur in the future. Corrective action: troubleshot spider gear, table tilt axis undemanded movement, k2 relay inactive due to safe circuit ordered pcb control. Recalibrate table tilt reference. Replaced table control pcb. Calibrate and tested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002749
MDR Report Key275713
Date Received2000-04-07
Date of Report2000-03-22
Date of Event2000-03-21
Date Added to Maude2000-05-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNI
Generic NameX-RAY TUBE
Product CodeITY
Date Received2000-04-07
Model Number9806-300-71202
Catalog NumberNA
Lot NumberNA
ID NumberSITE 82831
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key266865
ManufacturerPHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
Manufacturer Address710 BRIDGEPORT AVE. SHELTON CT 06484 US


Patients

Patient NumberTreatmentOutcomeDate
10 2000-04-07

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