MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY ST; TOMOGRAPHY, COMPUTED, EMISSION

Model Number PHP08M

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow-up report will be submitted after the investigation has been completed.

Event Description

It was reported that during tube warm-up with no one in the exam room, the operator heard a noise followed by the gantry covers being ejected from the gantry.No one was injured.

Manufacturer Narrative

It was reported that the top and side cover became detached during daily system preparation and fell to the floor.As recommended during system calibration, no one was in the room at the time of the event.The engineering team spoke with the fe who first went to the site.He said that only the side cover came off and that it was caused by the mounting hardware pin becoming dislodged; hence releasing the side cover, allowing it to drop.This happened on the first fastcal scan, after this mobile system had moved from its prior site, no one was nearby and no one was injured.Based on the original description that the covers "exploded" off the system, the fe checked for any sign of impact on the cover, he found none.He also checked for any signs that some part of the rotating part of the gantry had made contact with the covers, he found none.He was able to re-attach the cover to the gantry fixing the issue.The cover was not expelled.No part came loose inside the gantry.While ge mobile ct/pet systems are designed and tested for mobile transportation (product requirements include meeting gems standard 46-316745 for shock and vibrations) it is possible that a large pothole could have dislodged the mounting hardware enough to cause this issue.It is not definitively known if the cover dropped before the scan and that the vibration caused it to fall further or whether it had been dislodged by its journey (and all the others) and finally fell during the calibration phase.There is no trend of this failure mode.Risk assessment has concluded that the applied mitigations are effective and reduce the risk to as low as reasonably practical.No further practical mitigations are available to reduce the risk.Ge will continue to investigate and trend each mdr and related complaints.No further action is planned.

• Brand Name: DISCOVERY ST
• Type of Device: TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 7683481
• MDR Text Key: 113883055
• Report Number: 2126677-2018-00016
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• PMA/PMN Number: K041543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHP08M
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other