MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS DISCOVERY IGS 740; INTERVENTIONAL FLUOROSCOPIC X-RAY SY

Model Number XCA461, XCA461, XCA

Device Problems Device Maintenance Issue (1379); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Crushing Injury (1797); Bone Fracture(s) (1870)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

It was reported that during system maintenance in customer site, the ge healthcare (gehc) field engineer (fe) had his left hand caught and pinched underneath a table top for an hour.He was taken to the emergency department where x-rays were performed.It was determined that there were multiple fractures and misalignment to 2nd, 3rd, 4th and 5th digits.He was admitted to the hospital and had open reduction, multiple screws placed and amputation of left 4th digit (ring finger).

Manufacturer Narrative

On (b)(6) 2016 it was reported that a ge healthcare field service engineer employee had his hand crushed during table motor drive assembly replacement in customer site.The service manual requires the use of the loto (lock out tag out) tool to prevent the table from falling during the motor replacement but the investigation showed that ge healthcare field service engineer did not follow the appropriate manual instructions, even if the one followed by ge healthcare field service engineer requires also to use the same loto tool.Ge healthcare field service engineer completed all required trainings for discovery igs 740 system and was qualified to lead a discovery igs 740 system installation.But the innova iq table training was not a prerequisite.On december 12, 2016 training database was updated to have this training a prerequisite.On january 2, 2017 all usa ge healthcare field service engineers completed this training.On this specific site, customer did not allow loto tool kit to be on site due to infectious control standards.The loto tool kit not being on the site was not a contributing factor.The loto tool kit is now stored in the control room at this site.A new table was installed at customer site.Based on this analysis, no further action required.

• Brand Name: DISCOVERY IGS 740
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• Manufacturer (Section G): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• Manufacturer Contact: sabrina aadjou ; 283, rue de la minière; buc 78530 ; FR 78530
• MDR Report Key: 6085511
• MDR Text Key: 59396851
• Report Number: 9611343-2016-00015
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XCA461, XCA461, XCA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR