MAUDE Adverse Event Report: PHILIPS HEALTHCARE (SUZHOU) CO., LTD. INCISIVE CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	INCISIVE CT
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr# (b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.Philips suzhou factory detected an issue with incisive ct systems where the couch and gantry cant self-lock resulting in the couch to descend down / the gantry to tilt automatically at a very slow speed to its limit position or stop when reach a force balance point.This has been determined to be a reportable event.This issue is currently under investigation.
Additional Manufacturer Narrative
Philips suzhou factory detected an issue with incisive ct systems where the couch and gantry can¿t self-lock resulting in the couch to descend down and/or the gantry to tilt automatically at a very slow speed (about 0.4~2.8mm/second) to its limit position or stop when reach a force balance point.There was no harm as this issue was found in the factory.Based on investigation performed: philips suzhou factory identified a supplier nonconforming material issue from an incisive ct component in the production line.The supplier provided nonconforming actuators to philips which were used in philips ct systems and distributed to customer sites.These nonconforming actuators used in the ct gantry or couch could result in the gantry tilt or couch vertical self-lock to not work as expected.This was a material batch issue that occurred during a reading error of the bushing diameter, when the machining program was setup by the operator at the supplier.Probable cause: this was a material batch issue that occurred during a reading error of the bushing diameter, when the machining program was setup by the operator at the supplier.A correction for this issue is per gantry recall number: z-1265-2021 and couch recall number: z-1273-2021 internal reference complaint (b)(4).

• Brand Name: INCISIVE CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS HEALTHCARE (SUZHOU) CO., LTD.; no. 258, zhongyaun road; suzhou industrial park; suzhou jiangsu 21502 4; CH 215024
• MDR Report Key: 11315961
• Report Number: 3009529630-2021-00001
• Device Sequence Number: 715683
• Product Code: JAK
• UDI-Device Identifier: 00884838085015
• UDI-Public: 00884838085015
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

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
• Operator of Device: No Information
• Device Model Number: INCISIVE CT
• Device Catalogue Number: 728143
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/05/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1265-2021, Z-1273-2021
• Patient Sequence Number: 1