MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VERTEX; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number VERTEX PLUS / SOLUS / CARDIO-2154-3000A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

The issue reported was that a third-party general electric (ge) field service engineer (fse) was injured during a corrective maintenance service call on a vertex plus spect system.The system was not in clinical use when this occurred.Two 3rd party ge fse¿s were conducting a repair on the system when one of the two fse¿s felt a ¿pop¿ and discomfort/strain.The fse was seen by a physician, had an ultrasound, and later underwent surgery to repair a hernia.It was confirmed by the 3rd party service director: the fse¿s were formally trained on servicing the philips vertex system the fse¿s were using the appropriate documentation and online support while performing the repair.The 3rd party service stated the vertex system was not at fault for the injury sustained to the fse.Philips was unable to determine a probable cause for this event.Internal cross reference: complaint (b)(4).Health impact code: (b)(4) a severe injury, illness or impairment which requires hospitalization or medical intervention.(b)(4) one or more surgical procedures was required, or an existing procedure changed.Date of report: 2020903.

Event Description

This complaint has been evaluated based on the information provided.The issue reported was that a third-party field service engineer (fse) was injured during a corrective maintenance service call on a vertex plus spect system.The fse felt discomfort/strain while removing the pedestal from the table drive assembly.The fse was seen by a physician, had an ultrasound, and later underwent surgery to repair a hernia that resulted from the strain of lifting the pedestal.Based on the available information, this issue has been determined to be a reportable event.

• Brand Name: VERTEX
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 12422629
• MDR Text Key: 270494610
• Report Number: 3015777306-2021-10011
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• PMA/PMN Number: K952684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: VERTEX PLUS / SOLUS / CARDIO-2154-3000A
• Device Catalogue Number: 88297
• Distributor Facility Aware Date: 08/11/2021
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR