MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA AMBITION S; SYSTEM NUCLEAR MAGNETIC IMAGING

Model Number	INGENIA AMBITION S
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that the patient's fifth finger of the left hand was caught between the table top and the flex track cover during horizontal movement of the patient's bed.
Additional Manufacturer Narrative
Philips has started an investigation, a follow up report will be submitted once the investigation has been completed.
Additional Manufacturer Narrative
The primary root cause of this finger pinching related incident is use error.The user has not strictly followed the safety instructions and warnings to protect the patient.The finger pinching related incident could have occurred due to misuse by a person who was either untrained and unsupervised (violation of the ifu and local safety procedures), or by a trained employee who was not following the ifu and/or was also ignoring the warning labels (conscious decision to act in opposition to training and/or normal use instructions).In addition, no arm boards (protective measures to prevent finger pinching) were used at the time of the alleged harm (which, as stated ifu, should have been provided to prevent the patient from grabbing around the table sides and pinching the fingers during horizontal table motion, which is what happened in this event).This is considered an unfortunate incident that could have been prevented.The instructions for use clearly mentions this type of hazard and how to prevent it from happening.

• Brand Name: INGENIA AMBITION S
• Common Device Name: SYSTEM NUCLEAR MAGNETIC IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 20390737
• Report Number: 3003768277-2024-05737
• Device Sequence Number: 6566062
• Product Code: LNH
• UDI-Device Identifier: 00884838090057
• UDI-Public: 884838090057
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K18479
• 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): 11/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: INGENIA AMBITION S
• Device Catalogue Number: 781359
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/01/2024
• 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; Other
• Patient Age: 85 YR
• Patient Sex: Female