MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENUITY CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	INGENUITY CT
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint has been evaluated based on the information provided there is no allegation of death or serious injury.The issue reported was that improper packing for apm/cpm that was sent to the service engineer for replacement.Engineering initial review of the event has determined the risk is unacceptable.There is potential of harm.This event is currently under investigation, a supplemental report will be submitted when the investigation has been completed.Based on the available information, this issue has been initially determined to be a reportable event.
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: (b)(4).Date of report: (b)(6) 2022.
Additional Manufacturer Narrative
On (b)(6)2022, a fse (field service engineer) in indonesia stated that they have received the apm (anode power module) and cpm (cathode power module) with improper packing(with carton board box).The fse alleged that the improper packing may cause potential personnel injury to the service engineer when lifting the part manually.Engineering investigation was performed and concluded: ¿ the proper apm/cpm fru parts packing should be with a flight case with handles and wheels, which will allow service engineer to be able to lift the handles and to move the part to the desired position.¿ spellman high voltage supplies apm (anode power module) and cpm (cathode power module) parts to philips ct business unit (bu) production and services and solutions deliver (ssd) service parts supply chain (sps).The packaging requirements for ct bu production parts and sps fru parts are different.The ct bu production parts are required with cardboard box with wood structure/support.Considering the safety installation during service, specific sps fru parts are required to be shipped in flight cases (fc).¿ the actual apm/cpm fru part which fse received was found with cardboard box with wood structure/support ¿ fse confirmed that the service work was continued with an extra manpower to lift the part manually, move and replace the part.The part was lifted to an estimated height of 10~50cm.There was no report of harm as a result of this event.Service personnel performing the service activities on the ct systems are expected to have training in safety precautions of taking/lifting heavy components.Service personnel can recognize easily that an 80kg mass is too heavy for a single person to lift, therefore, service personnel would be expected to seek out the necessary tooling and additional personnel as required to safely handle moving the spellman generator part into place for installation.There were no apm/cpm fru parts with improper packing to fall to the floor and injure the service personnel.There was no harm as a result of this event.This malfunction would not be likely to cause or contribute to a death or serious injury if this were to recur.Based on the further investigation, this issue has been determined not to be a reportable event probable cause: gantry generator were found shipped with carton board box instead of the flight case packing internal cross reference: complaint pr# (b)(6).Date of report 20220809.

• Brand Name: INGENUITY CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: crystal dean ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 14713030
• Report Number: 3015777306-2022-00003
• Device Sequence Number: 17451511
• Product Code: JAK
• UDI-Device Identifier: 00884838059511
• UDI-Public: 00884838059511
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K160743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: Health Professional
• Device Model Number: INGENUITY CT
• Device Catalogue Number: 728326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown