CINE CAMERA - ARRITECHNO CAMERA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-30 for CINE CAMERA - ARRITECHNO CAMERA manufactured by Siemens Medical Systems, Inc..

Event Text Entries

[2155] Cine camera fell from mount striking patient's right forearm. The patient suffered no further untoward effects. An x-ray of the patient's right forearm was negative. Safety cable slipped from mount flange and failed to prevent camera from falling. Siemens field service report attacheddevice 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:. 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, visual examination. Results of evaluation: component failure, material degradation/deterioration, other. 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, device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3593
• MDR Report Key: 3593
• Date Received: 1992-12-30
• Date of Report: 1992-10-08
• Date of Event: 1992-10-07
• Date Facility Aware: 1992-10-07
• Report Date: 1992-10-08
• Date Reported to FDA: 1992-10-08
• Date Reported to Mfgr: 1992-10-07
• Date Added to Maude: 1993-04-26
• 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: 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

• Generic Name: CINE CAMERA - ARRITECHNO CAMERA
• Product Code: IZJ
• Date Received: 1992-12-30
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3333
• Manufacturer: SIEMENS MEDICAL SYSTEMS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-12-30