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

Model Number 722012

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); No Known Impact Or Consequence To Patient (2692)

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 during the procedure the cover of the l-arm of the system detached and hit the shoulder of the operator.The user had some bruising because of the cover hitting his shoulder.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips investigated this complaint.Philips checked the system on site and confirmed that the safety chain used to prevent the l-arm cover from falling failed.The safety chain was reattached and the cover was reinstalled.The system was returned to use in good working order.Since then, the issue has not reoccurred.User suffered minor bruising and swelling of the shoulder and was given anti-swelling medication.No patient harm has been reported to philips.Philips has opened an investigation as a follow up for the noted complaint.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 8915578
• MDR Text Key: 155185340
• Report Number: 3003768277-2019-00068
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

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: 722012
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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 Age: 31 YR
• Patient Weight: 75