CARDIAC CX 620010 62001G *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-12 for CARDIAC CX 620010 62001G * manufactured by Fischer Imaging Corp..

Event Text Entries

[54322] 44 year old male undergoing a radiofrequency ablation. The c-arm bolt snapped. The c-arm went from an ap projection to a lateral position. The pt received no injuries. The procedure was aborted, the pt's heart was paced out of atrial flutter into normal sinus rhythm, he remained in normal sinus rhythm and was discharged to home the following day.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 92301
• MDR Report Key: 92301
• Date Received: 1997-05-12
• Date of Report: 1997-04-21
• Date of Event: 1997-04-08
• Date Facility Aware: 1997-04-08
• Report Date: 1997-04-21
• Date Added to Maude: 1997-05-23
• 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: 3
• Initial Report to FDA: 3
• 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: CARDIAC CX
• Generic Name: RADIOGRAPHIC EQUIPMENT
• Product Code: ITY
• Date Received: 1997-05-12
• Returned To Mfg: 1997-04-08
• Model Number: 620010 62001G
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Expiration Date: 2011-11-11
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 91175
• Manufacturer: FISCHER IMAGING CORP.
• Manufacturer Address: 12300 NORTH GRANT ST. DENVER CO 802413120 US
• Baseline Brand Name: *
• Baseline Generic Name: *
• Baseline Model No: 62001G
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-05-12