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

Model Number 722001

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Hair Loss (1877)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up will sent to the fda.

Event Description

Philips received a complaint from the customer in which was stated that a patient suffered from hair loss after an emergency aneurysm.The patient had 3 studies in 2 weeks which resulted in an accumulated dose of 6.5 gy.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: a philips field service engineer (fse) came onsite and was informed by the customer that the study was extensive with 60 cine runs on the same spot of the patients head.The fse troubleshot the system and found that the fda limit rule of 10 r/min edl limit was set on "false" in the examination programmed x-ray (epx), which was requested by the customer.He found that the entrance dose limitation (edl) calibration was going up to 20 r/min as a result.It is allowed in argentina to set the fda limit rule of 10 r/min edl limit on "false" in the epx.The fse performed a level 1 image quality (iq) check which showed that only the edl limit failed because the level 1 iq check does not accept and edl limit of 20 r/min.The system passed the level 1 iq check after the fse changed the epx settings to set the system to the fda limit rule of 10 r/min and recalibrated the system.The fse returned the system back to the customer in working order.The philips complaint investigator and the system designer collected an reviewed all available evidence and learned that the patient was treated three times in two weeks time, but no dose reports could be provided for the other two treatments.We could not find any evidence that the system did not function correctly.The fact that the system was set to 20 r/min did not increase the dose received by the patient since the dose control loop controls the amount of radiation output to the optimal dose value.The radiation output will only go above 10 r/min with very large patients, which is not the case for the patient of the reported issue ((b)(6)).The event log file did not indicate any dose related system malfunction.The dose (total air kerma) of 6.5 gy received by the patient is not unusual with the reported circumstances taken into account.The amount of dose received by the patient can lead to hair loss, especially when all of the dose enters one spot on the patients head.Also the fact that this patient was treated 3 times within 2 weeks makes the chance on hair loss bigger for this patient.Conclusion: we could not find any evidence that the system did not function correctly.The hair loss experienced by the patient is a possible side effect of the procedures, when looking at the dose given to the patient.

• Brand Name: ALLURA XPER FD10 C
• 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
• 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: 6266032
• MDR Text Key: 65356432
• Report Number: 3003768277-2017-00001
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2016

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: 722001
• Device Catalogue Number: 722001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2004
• 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): Other
• Patient Age: 32 YR
• Patient Weight: 80