MAUDE Adverse Event Report: INGENUITY CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	INGENUITY ELITE 128
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The issue reported was that while positioning an unconscious patient, the customer did not support/restrain the patient's arms, and they bumped/fell against the gantry mylar ring.This led to the mylar ring being damaged, which caused a laceration to the patient's arm requiring stitches.The system was in clinical use when this occurred.The philips field service engineer (fse) went on site to evaluate and confirm the reported issue.The fse confirmed that the patient was unconscious and had moved randomly when being positioned on the scanning couch.The patient bumped his arm against the gantry mylar ring, which led to the mylar ring damage and patient's arm injury.The fse reported that the patient wound was about 3-5 centimeters long and 0.3 centimeters deep.When this occurred, the customer pressed the e-stop (emergency stop) button and stopped clinical use of the system.The patient's arm injury was treated with stitches.Philips engineering reviewed the details of the event and concluded that there was no malfunction of the system, this was use error of not making sure the patient¿s arms were strapped/supported securely on the table.The operator is to ensure that the patient is placed and strapped securely on the patient table and to keep the patient under continuous observation during all movements of the gantry and the patient table.The probable cause was use error in not securely strapping/supporting the unconscious patient¿s arms.Internal cross reference: complaint pr# (b)(4).Health impact code: (b)(4); a severe injury, illness or impairment which requires hospitalization or medical intervention.Date of report: 20210823.
Event or Problem Description
This complaint has been evaluated based on the information provided.The issue reported was that while positioning an unconscious patient, the patient's arm was not secured and bumped against the gantry mylar ring.This led to the mylar ring being damaged causing a laceration to patient's arm injury which required stitches.There was no malfunction of the system; it is working as specified.Based on the available information, this issue has been determined to be a reportable event.

• Brand Name: INGENUITY CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 12357304
• Report Number: 3015777306-2021-10009
• Device Sequence Number: 11848694
• Product Code: JAK
• UDI-Device Identifier: 00884838059504
• UDI-Public: 00884838059504
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Model Number: INGENUITY ELITE 128
• Device Catalogue Number: 728323
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention