MAUDE Adverse Event Report: CARESTREAM HEALTH INC. DRX-ASCEND SYSTEM

Model Number	1021732
Medical Device Problem Code	Radiation Overexposure (3017)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Csh investigation is currently in progress.Submitting an initial report to the us fda as there are currently insufficient facts available to make a reportability decision and at least 27 days has elapsed.Csh will submit a follow up with investigation update/findings within 30 days.Udi number and manufacturing date are not available at time of this report, will update follow up report with udi number and manufacturing date.
Event or Problem Description
On 19-oct-22, carestream health (csh) was notified of an incident related to the drx ascend system: the generator did not abort after error (er51) and continued the exposure.There has been no injury reported.Csh investigation is currently in progress.Submitting an initial report to the us fda as there are currently insufficient facts available to make a reportability decision and at least 25 days has elapsed.Udi number and manufacturing date are not available at time of this report, will update follow up report with udi number and manufacturing date.
Additional Manufacturer Narrative
Csh investigation is currently in progress.An initial report was submitted to the us fda on november 17, 2022, as there were currently insufficient facts available to make a reportability decision.Submitting a follow-up report as the investigation is still ongoing and there are still insufficient facts available to make a reportability decision.Udi number and manufacturing date are not available at time of this report, will update follow up report with udi number and manufacturing date.
Event or Problem Description
On 19-oct-22, carestream health (csh) was notified of an incident related to the drx ascend system: the generator did not abort after error (er51) and continued the exposure.There has been no injury reported.Csh investigation is currently in progress.An initial report was submitted to the us fda on november 17, 2022,as there were currently insufficient facts available to make a reportability decision.Submitting a follow-up report as the investigation is still ongoing and there are still insufficient facts available to make a reportability decision.Udi number and manufacturing date are not available at time of this report, will update follow up report with udi number and manufacturing date.
Event or Problem Description
On 19-oct-22, carestream health (csh) was notified of an incident related to the drx ascend system: the generator did not abort after error (er51) and continued the exposure.There has been no injury reported.Csh investigation is currently in progress.An initial report was submitted to the us fda on november 17, 2022,as there were currently insufficient facts available to make a reportability decision.Submitting a follow-up report as the investigation is still ongoing and there are still insufficient facts available to make a reportability decision.Update: the operator was doing an abdomen study and the generator did not abort the exposure after the feedback error (er51) and continued the exposure until the anode heat error (er027), producing 3222.7 mas and 5307.4 ms.The backup mas was set to 100mas.
Additional Manufacturer Narrative
Csh investigation is currently in progress.An initial report was submitted to the us fda on november 17, 2022, as there were currently insufficient facts available to make a reportability decision.Submitting a follow-up report as the investigation is still ongoing and there are still insufficient facts available to make a reportability decision.Update: conclusion: based on the risk analysis, 1) after investigating the logs, all reported abnormal value cases were under the aec mode (controlled automatic exposure), which indicates no potential hazard risk to users or patients; 2) even if these exposures were operated in manual mode, the exposure mechanism ensured that no over exposure situation would occur.3) based on the analysis of the image quality and the dose value from the dap, there were no potential over-exposures to users or patients.Root cause analysis: after becoming aware of the issue, the defect mcb board at the customer site has been replaced and a re-calibration has been performed based on the instruction from service manual, no further similar issues were reported.The defect mcb was send back to shanghai r&d, team conducted multiple exposure experiments with similar configurations with the ones at the customer site and generator re-calibrated.Based on the analysis of the above information and potential failure situation, it was considered that an incorrect calibration data caused this incorrect post exposure time displayed value which can be fixed by performing a calibration on the high-voltage generator.Break-fix.There have been no other reports of this kind, carestream has concluded this investigation.

• Brand Name: DRX-ASCEND SYSTEM
• Common Device Name: DRX-ASCEND SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester NY 14608
• Manufacturer (Section G): RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED; building 7, no. 1510 chuanqiao; pilot free trade zone shanghai; shanghai, 20120 6; CH 201206
• Manufacturer Contact: alejandra benitez ; 150 verona street; rochester, NY 14608 ; 1585627853
• MDR Report Key: 15813875
• Report Number: 3004105475-2022-00012
• Device Sequence Number: 5686756
• Product Code: KPR
• UDI-Device Identifier: 60889971023148
• UDI-Public: (01)60889971023148(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K011486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1021732
• Device Catalogue Number: 1023142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 10/19/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/19/2022; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown