MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722003

Device Problem Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

It has been reported to philips that a nurse suffered from laceration of the finger when moving the table top.No medical intervention was required.According to the information received, the nurse was moving the table top back towards the foot end of the table and her hand was placed in the track on the bottom side of the table.The nurse pinched her hand in the track during movement as the tabletop rolled back.

Manufacturer Narrative

Philips investigated this complaint.No damage was found on the table and it was according to specifications.The instructions for use of the system (4522 203 17232, pages 3-14) 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¿.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8464268
• MDR Text Key: 140602867
• Report Number: 3003768277-2019-00026
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1