MAMMOGRAPHY 4512-129-27531 N/I

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-15 for MAMMOGRAPHY 4512-129-27531 N/I manufactured by Philips.

Event Text Entries

[344] Radiation technician performing the oblique projection on patient with the mamogram, when the compression would not release the breast. The patient was not injured. The mammogram has been taken out of operation and is being replaced with a new one. The old machine had been returned to philips, the manufacturerdevice not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jul-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, performance tests performed. Results of evaluation: mechanical problem, telemetry failure, none or unknown, safety interlock/feature failure. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor, device temporarily removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1340
• MDR Report Key: 1340
• Date Received: 1992-09-15
• Date of Report: 1992-09-01
• Date of Event: 1992-08-26
• Date Facility Aware: 1992-08-26
• Report Date: 1992-09-01
• Date Reported to FDA: 1992-09-01
• Date Reported to Mfgr: 1992-08-27
• Date Added to Maude: 1992-09-23
• 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: MAMMOGRAPHY
• Generic Name: N/I
• Product Code: IYQ
• Date Received: 1992-09-15
• Model Number: 4512-129-27531
• Catalog Number: N/I
• Lot Number: N/I
• ID Number: 822787 TUBE SERIAL NUMBER
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAR-88
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1284
• Manufacturer: PHILIPS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-09-15