SHIMADZU HD 150G-60 0162548602 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 1993-01-19 for SHIMADZU HD 150G-60 0162548602 N/A manufactured by Shimadzu Corportation.

Event Text Entries

[2182] Patient having bariem enema compresses bowel area with paddle to move bariem paddle froze in down position. Patient returned to x-ray department next day complaint of rib pain, x-ray taken found rib fracture. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jul-91. Service provided by: independent factory trained/authorized 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, mechanical tests performed. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: maybe. 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: 3831
• MDR Report Key: 3831
• Date Received: 1993-01-19
• Date of Report: 1992-10-20
• Date of Event: 1992-05-21
• Date Facility Aware: 1992-05-21
• Report Date: 1992-10-20
• Date Added to Maude: 1993-05-06
• 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: SHIMADZU HD 150G-60
• Generic Name: SHIMADZU RS-100 FLOURO TABBLE
• Product Code: FCD
• Date Received: 1993-01-19
• Model Number: 0162548602
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 3573
• Manufacturer: SHIMADZU CORPORTATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-01-19