MAUDE Adverse Event Report: GE HEALTHCARE INNOVA IGS 520; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number DIVA 2X150 GB SATA 2.5 DISC

Device Problems Device Alarm System (1012); Data Back-Up Problem (2902)

Patient Problem No Information (3190)

Event Date 02/04/2016

Event Type  malfunction  

Event Description

Patient qualified for percutaneous intervention of an st elevated myocardial infarction (stemi).Equipment readiness completed prior to the start of the case and showed full function including recording of images.No full disc warning was seen.Patient brought to the cath lab placed on table and prepped.Vascular access obtained.At the start of the procedure the functionality of the image disc registered as full and no images could be recorded.No warning to the user of a full disc.System rebooted with no correction.Patient had to be moved to another cath lab for completion of the procedure.Follow up to the equipment by the field engineer detected a corrupt disc.Disc was clean and showed 99% capacity.Driver and disc were replaced.Manufacturer response for image disc, (brand not provided) (per site reporter): a ge liaison is on campus as contracted employee and responded to this incident.A field engineer responded to the incident and completed the replacement of the faulty disc and driver.

Event Description

Patient qualified for percutaneous intervention of an st elevated myocardial infarction (stemi).Equipment readiness completed prior to the start of the case and showed full function including recording of images.No full disc warning was seen.Patient brought to the cath lab placed on table and prepped.Vascular access obtained.At the start of the procedure the functionality of the image disc registered as full and no images could be recorded.No warning to the user of a full disc.System rebooted with no correction.Patient had to be moved to another cath lab for completion of the procedure.Follow up to the equipment by the field engineer detected a corrupt disc.Disc was clean and showed 99% capacity.Driver and disc were replaced.Manufacturer response for image disc, (brand not provided) (per site reporter): a ge liaison is on campus as contracted employee and responded to this incident.A field engineer responded to the incident and completed the replacement of the faulty disc and driver.

• Brand Name: INNOVA IGS 520
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): GE HEALTHCARE; c/o eileen fick mailcode w440; 3000 n. grandview blvd.; waukesha WI 53188
• MDR Report Key: 5562749
• MDR Text Key: 42169708
• Report Number: 5562749
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2016,03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIVA 2X150 GB SATA 2.5 DISC
• Device Catalogue Number: 2335129-8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 89 YR