OMNIPLANE FILM CHANGER ONP-200 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-11 for OMNIPLANE FILM CHANGER ONP-200 N/A manufactured by Medrad.

Event Text Entries

[3079] On 5/10/93, this equipment was tobe used for a carotid andx vertebral angiogram. On the third set of films, the equipment faulted. On two subsequent sets of films, the equipment failed again. The procedure was then terminated by the doctor. The patient experienced blindness after the procedure; it did clear within 24 hoursdevice 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-may-93. Service provided by: factory trained/authorized/owned service organization. Service records available. 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, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: component failure, invalid data. 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. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4965
• MDR Report Key: 4965
• Date Received: 1993-06-11
• Date of Report: 1993-05-18
• Date of Event: 1993-05-10
• Date Facility Aware: 1993-05-10
• Report Date: 1993-05-18
• Date Reported to Mfgr: 1993-05-10
• Date Added to Maude: 1993-06-21
• 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: OMNIPLANE FILM CHANGER
• Generic Name: SAME
• Product Code: IZP
• Date Received: 1993-06-11
• Model Number: ONP-200
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: SOFTWARE VERSION 3.0 PI
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4669
• Manufacturer: MEDRAD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-06-11