SAME CIRCULAR 17" UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-10 for SAME CIRCULAR 17" UNKNOWN manufactured by Phillips Medical Systems.

Event Text Entries

[17762265] While using 17 cm circular coil for scanning a lumbar spine, patient complained of heat to the buttocks. We immediately moved patient off of surface coil. She experience minimal erythemia that dissipated before leaving the departmentdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jun-92. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3326
• MDR Report Key: 3326
• Date Received: 1992-07-10
• Date of Report: 1992-07-10
• Date of Event: 1992-06-03
• Date Facility Aware: 1992-06-03
• Report Date: 1992-07-10
• Date Reported to Mfgr: 1992-06-03
• Date Added to Maude: 1993-04-15
• 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: 0
• Initial Report to FDA: 0
• 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: SAME
• Generic Name: SURFACE COIL
• Product Code: FKD
• Date Received: 1992-07-10
• Model Number: CIRCULAR 17"
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3112
• Manufacturer: PHILLIPS MEDICAL SYSTEMS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-10