MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, INC.; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problem Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2019

Event Type  malfunction  

Event Description

When attempting to initiate x-ray equipment for scheduled catheter procedure for an urgent catheter, as physician stepped on pedal to activate, x-ray did not come on, despite multiple attempts with pedal.System shut down and restarted and then pedal worked.Clinical engineering called in which i was directed to information systems, information systems paged out to clinical engineering on call and waited for call back.Gary from clinical engineering called back and stated he was at a nearby site and would head over when he was finished.He never showed up.We reset system at end of case and performed an xray test in which the x-ray worked.We were paged in for a myocardial infarction alert- same issue occurred with pedal and start of x-ray.Cath lab supervisor paged and informed of event- she paged clinical engineering again and they arrived after case to change out the xray pedal and assess equipment.

Event Description

When attempting to initiate x-ray equipment for scheduled catheter procedure for an urgent catheter, as physician stepped on pedal to activate, x-ray did not come on, despite multiple attempts with pedal.System shut down and restarted and then pedal worked.Clinical engineering called in which i was directed to information systems, information systems paged out to clinical engineering on call and waited for call back.Clinical engineering called back and stated he was at a nearby site and would head over when he was finished.He never showed up.We reset system at end of case and performed an xray test in which the x-ray worked.We were paged in for a myocardial infarction alert- same issue occurred with pedal and start of x-ray.Cath lab supervisor paged and informed of event- she paged clinical engineering again and they arrived after case to change out the xray pedal and assess equipment.

• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, INC.; 3000 n grandview blvd; waukesha WI 53188
• MDR Report Key: 9580386
• MDR Text Key: 174702557
• Report Number: 9580386
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2020
• Type of Device Usage: N
• Patient Sequence Number: 1