MAMMOGRAPHY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-30 for MAMMOGRAPHY manufactured by Siemens.

Event Text Entries

[430] Pt having a mamogram (left axillary view) - machine shut down during exposure before film was exposed. Pt was in full compression for about 2 minutes before machine would come back updevice not labeled for single use. Patient medical status prior to event: unknown. There was multiple patient involvement. Number of patients involved:. 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, a device from same lot was evaluated, other, other. Results of evaluation: invalid data, invalid data, invalid data. Conclusion: device failed during assembly, device failed during assembly, device failed just prior to use, other. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, invalid data, invalid data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 431
• MDR Report Key: 431
• Date Received: 1992-03-30
• Date of Event: 1992-02-26
• Date Facility Aware: 1992-02-26
• Date Added to Maude: 1992-04-28
• 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: MAMMOGRAPHY
• Product Code: IYQ
• Date Received: 1992-03-30
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-AUG-86
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 425
• Manufacturer: SIEMENS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-03-30