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

Model Number 722008

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

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 the dose was flagged up by the system during the end of an interventional cardiac procedure.No harm to the patient has been reported to philips has started an investigation for this complaint.

Manufacturer Narrative

Philips investigated this complaint.The customer reported that the procedure resulted in a dose area product (dap) of 396 gy.Cm2, where the customer expected to have a dose area product value of 50 gy.Cm2.The procedure took place on (b)(6)2019.No patient harm has been reported to philips.According to the information provided to philips by the customer, the screening time was 29 minutes and 16 seconds and the patient was overweight.Despite the good faith effort performed by philips, no other information on the patient has been received.The customer did not note any system malfunction during the procedure.Philips has checked the service history of the system.Reports of the planned maintenance of the system that occurred prior to the incident (b)(6)2019 and after (b)(6)2019 the reported incident show that all tests passed and the system was working as designed and within specifications.The system log file for this event is not available on the system and the customer did not provide the patient dose report, therefore further investigation to the cause, based on system information, cannot be performed.The weight of the patient has a direct relation on the dose required for image quality during procedures.As no system malfunction has been confirmed, the most likely cause for the unexpected high dose is the size of the patient which requires the use of high dose runs.Consequently, philips has closed this 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 BIPLANE
• 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: 9322441
• MDR Text Key: 174182470
• Report Number: 3003768277-2019-00091
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K033737
• 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: 10/17/2019

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: 722008
• Device Catalogue Number: 722008
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR