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

Model Number INGENUITY CORE 64

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was 5 of 5 fasteners securing the ct couch to the floor were dislodged and that there is potential for the couch to tip.The system was not in clinical use at the time.Based on information known at this time, this issue has been determined to be a reportable event.The issue is currently under investigation.

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.(b)(4).Date of report: (b)(6) 2022.

Manufacturer Narrative

The issue reported was 5 of 5 fasteners securing the ct couch to the floor were dislodged and that there is potential for the couch to tip.The system was not in clinical use at the time.The customer¿s in-house engineer leaned on the couch and found it almost tip to the side (left and right) direction, therefore, reported the issue to philips.A philips field service engineer (fse) went to the site and evaluated the system.It was found that when the couch was intentionally pushed or pulled, it had side to side movement; however, the anchors were still in place so the couch could move slightly, but it would not tip over.The fse further concluded that all five anchors had lifted around 1/2 inch from the concrete floor and screw/washers were well tightened.Also visually there was some concrete around the hole broken in pieces.There was no direct cause found on site for the loose anchors.The fse re-secured 4 of 5 anchors back into place and return systemed to customer as the customer did not want any further downtime of the system to address the 5th anchor.Philips instructed the customer to halt use of the system until further investigation was performed.The fse re-visited the site and removed all 5 previous anchors.Then replaced with new anchors with a higher pull specification.Philips fse confirmed that since the end of 2020, routine maintenance /preventative maintenance on this device has been performed by the in-house service organization, not philips.A structural engineer through the customer performed an onsite concrete review and investigation which concluded the following: the architectural drawings indicate that a 1 ½¿ topping slab was poured on the 2 ½¿ structural slab.However, the topping slab specified is unclear and presumably is a concrete like material that may be inferior to concrete, with unknown strength and bonding characteristics.Typically, topping slabs are not considered structural and are usually specified for floor levelling and as a subbase for floor finishes.The structural engineer recommended to install a through bolt anchor.Per the installation record for this device, the system was properly secured during installation in 2018 by philips.Philips site preparation document stated that ¿the customer their structural engineer of record and builder/contractor assumes all risks and liability in these cases¿.Specifically, the requirement for anchoring has been stated in site preparation document.Also, according to the site preparation drawing by installation team and signed by customer, stated customer is responsible for floor strength.The philips fse then worked with customer's structural engineer and implemented the recommendation of the structural engineer by installing a through bolt anchor.The structural engineer reviewed the site and approved it.Probable cause: customer concrete strength does not meet specification.Based on the conclusion of this event, it is considered not reportable.

• Brand Name: INGENUITY CT
• Type of Device: 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: beth johnson ; veenpluis 4-6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 15334262
• MDR Text Key: 299048343
• Report Number: 3015777306-2022-00006
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838059498
• UDI-Public: 00884838059498
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: INGENUITY CORE 64
• Device Catalogue Number: 728321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1