MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DEFINIUM 8000; STATIONARY X-RAY SYSTEM

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare investigation has been initiated.A follow-up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

On 30-apr-2018, the ge field engineer (fe) was troubleshooting collimator blade misalignment on a definium 8000 system at (b)(6) hospital in the usa when he noticed the collimator mounting screws were partially backed out.The customer informed the ge fe that the collimator was recently replaced by a philips service representative.To correct this issue, the ge fe replaced the collimator per the service manual instructions and recalibrated the positioner.The collimator did not detach and fall and there was no injury related to this event.

Manufacturer Narrative

Ge healthcare¿s root cause investigation has been completed and the cause of this incorrectly mounted collimator was determined to be a service error.The ge field engineer (fe) stated he was originally notified by the customer the collimator was misaligned.The fe also stated this site is normally serviced by a third-party service provider, but they could not correct the misalignment and therefore the customer contacted ge service.The customer also informed ge the third-party service provider recently removed the collimator due to an unrelated service activity.When the ge fe arrived at the site for troubleshooting, he observed the siemens collimator was mounted incorrectly as the detent arm was under the mounting ring and the three mounting screws were protruding out from their holes which are both obvious signs of incorrect installation.To correct this issue, he replaced the collimator according to the service manual instructions and re-calibrated the system positioner calibrations.The third-party service provider was contacted, but they would not supply any additional information regarding this event.No further actions are needed.

• Brand Name: DEFINIUM 8000
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7552851
• MDR Text Key: 109639858
• Report Number: 2126677-2018-00011
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K051967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

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
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1