MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD10

Device Problem Entrapment of Device (1212)

Patient Problems Crushing Injury (1797); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 08/11/2021

Event Type  Injury  

Event Description

It has been reported to philips that during an interventional procedure the operator injured his fingers as they got jammed while moving the table.The two fingers got cuts, bleeding, severe pain and swelling for days.Philips has started an investigation of this complaint.

Manufacturer Narrative

Addt narrative: philips investigated this complaint.According to the information collected, the operator grabbed the longitudinal rail while moving the tabletop to guide the movement.The fingers of the operator became entrapped in the longitudinal guiding profile of the table during this movement resulting in injury to two fingers.The injury was treated with bandage.The instructions for use of the system (9897 100 04241, page 2-17) include a warning regarding access to the longitudinal guiding profiles of the table: ¿personnel should be aware that it is possible to access the longitudinal guiding profiles from underneath the tabletop.Serious injury may result if any part(s) of the personnel present become trapped in the longitudinal guiding profiles¿.There was no malfunction of the system.Corrected data: patient information has been updated in the initial report outcomes attributed to the ae was mistakenly classified "required intervention".Treatment with bandage is not classified as a treatment that will prevent permanent damage to a body structure, therefore the selection has been updated to "other".Updated the patient outcome codes, evaluation result code, component code and conclusion code as per the outcome of the investigation.

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12638831
• MDR Text Key: 276592534
• Report Number: 3003768277-2021-10178
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD10
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 50 KG