MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722028

Device Problem Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It has been reported to philips that at the end of a case the nurse moved the table top, using her left hand on the bottom of the table top.The nurse suffered from damage to the index, middle and ring fingers and the breakage of a phalanx bone of the ring finger.

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.¿ philips has opened an investigation as a follow up for the noted complaint.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 FD20
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8207803
• MDR Text Key: 131767190
• Report Number: 3003768277-2019-00001
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K141979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

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: 722028
• Device Catalogue Number: 722028
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention