MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA ELITION S; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA ELITION S
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips has started an investigation, a follow up will be submitted once completed.
Event or Problem Description
Philips received a report that a radiology technician tried to clean the sacu filter, stuck her hand in the vent pipe where her hand got caught by the running fan.She suffered serious injuries to 2 of her fingers , 1 of which was partially amputated as a result.
Additional Manufacturer Narrative
The customer reported that an mr operator tried to check if the outlet of the system air cooling basic unit (sacu) was blocked, after several malfunctions occurred (smoke alarm without cause) of the installed smoke detector (installed by philips) of an ¿ingenia elition s¿-system.The mr operator reached with his hand into the sacu outlet.The sacu did not have a flexible hose connected on the outlet connecting it to the hospital air system, rather it was venting inside the technical room the system was not in clinical use at time of the incident, however the fan inside the sacu was activated.The customer confirmed that the mr operator knew the fan was activated but continued checking the outlet as they did not know how to turn the fan off.Note: the mr operator is not trained to execute service/ maintenance.As a result, the hand of the mr operator got caught by the running fan inside the sacu outlet, resulting in a serious injury to two of the fingers.One finger was partially amputated as a result.Based on the findings derived from our investigation, the incident in question is deemed to be an isolated local incident that could have been prevented.There was no malfunction of the system that contributed to this incident.

• Brand Name: INGENIA ELITION S
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 19085886
• Report Number: 3003768277-2024-02172
• Device Sequence Number: 20746277
• Product Code: LNH
• UDI-Device Identifier: 00884838088108
• UDI-Public: 884838088108
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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
• Device Model Number: INGENIA ELITION S
• Device Catalogue Number: 781357
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown