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

Model Number ALLURA XPER FD10

Device Problem Entrapment of Device (1212)

Patient Problems Crushing Injury (1797); Laceration(s) (1946)

Event Date 03/30/2022

Event Type  Injury  

Event Description

It has been reported to philips that a nurse injured her finger while moving the table top.According to the information collected, the nurse was attempting to move the table in a longitudinal direction when her finger got caught between the table rail and the upper cover of the table base.The fingernail was cut in half and stitches were required.Philips has started an investigation of this complaint.

Manufacturer Narrative

Corrected data: some more detailed information was received about the incident, so incident description was updated.In addition, patient outcome code and health impact code were updated due to discrepancy.

Event Description

It has been reported to philips that a nurse injured her finger while moving the table top.According to the information collected, the table top was hard to move in longitudinal direction and the nurse grabbed the table rail to guide the movement.While moving, her finger got caught between the table rail and the upper cover of the table base.The fingernail was cut in half and stitches were required.The nurse will be on sick leave for two weeks.Philips has started an investigation of this complaint.

Manufacturer Narrative

Additional narrative: a philips service engineer inspected the ad7 table onsite.The difficulty in moving the table top longitudinally was caused by metal dust on the longitudinal table brake.The table brake rail was cleaned, and the longitudinal table brake was replaced as a preventive measure.The system was returned to use in good working order.The instructions for use of the system (9897 100 04241, pages 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¿.Philips discussed this warning in the instructions for use with the customer, and customer confirmed that they were aware of this warning.Based on the investigation of this complaint, philips concludes that the finger entrapment was not caused by a malfunction of the system.Corrected data: patient weight, 510k, product brand name, fda product code, common device name, model number, catalog item identifier, serial number, device identifier (gtin), manufacture date, labeled for single use.

• Brand Name: ALLURA
• 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: 14041949
• MDR Text Key: 288781193
• Report Number: 3003768277-2022-00150
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838085251
• UDI-Public: 00884838085251
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,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?: Yes
• 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: 03/30/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 03/30/2022; 03/30/2022
• Supplement Dates FDA Received: 04/08/2022; 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2009
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 60 KG