FISCHER IMAGING PROFILE 90 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 1993-03-08 for FISCHER IMAGING PROFILE 90 N/A manufactured by Fischer Imaging.

Event Text Entries

[21965126] Patient was in radiology department for be with gastrografin exam. During exam it was necessary to move patient caudad. This was accomplished by moving the table. When the technologist looked, it appeared the patient had his fingers under the pillow, so continued to move the table until the patient notified him that his finger was caught, technoloist immediately removed it, contacted supervisor, wrapped finger, x-rayed it and completed exam. Supervisor notified chief radiologist, nursing supervisor for 309b and alerted them that x-ray revealed a fracture. Patient was returned to beddevice 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-jan-92. Service provided by: factory trained/authorized/owned service organization. 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: design - inadequate. Conclusion: intermittent failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3090
• MDR Report Key: 3090
• Date Received: 1993-03-08
• Date of Report: 1992-07-01
• Date of Event: 1992-02-17
• Date Facility Aware: 1992-02-17
• Report Date: 1992-07-01
• Date Reported to Mfgr: 1992-02-18
• Date Added to Maude: 1993-04-06
• 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: FISCHER IMAGING
• Generic Name: FISCHER IMAGING
• Product Code: IXK
• Date Received: 1993-03-08
• Model Number: PROFILE 90
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: TYPE 59600GB
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2891
• Manufacturer: FISCHER IMAGING

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-03-08