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

Model Number 722003

Device Problem Sticking (1597)

Patient Problem Radiation Overdose (1510)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

The bottom of the pedal was sticking to floor due to a sticky substance like contrast field service engineer did test old footswitch prior to replacing it by stepping on fluoro pedal and it stuck to the mat below it, he moved the entire footswitch laterally across the mat a few cm and the pedal released.This symptom led him to believe it was sticking to the mat because of a sticky substance on bottom of pedal like contrast.When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which was stated that the foot pedal was sticking to the floor mat, this resulted in 4-5 minutes of extra radiation for the patient.The total dose for the patient in this procedure was 2.32 gy.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: the philips field service engineer (fse) went onsite and found that the bottom of the fluoroscopy pedal was sticking to the floor due to a sticky substance like contrast.He stepped on the fluoroscopy pedal and it stuck to mat below.He subsequently moved the entire foot switch a few centimeters laterally across the mat which released the pedal.This symptom led the fse to the conclusion that the foot switch pedal was sticking to mat because of a sticky substance on bottom of pedal like contrast the fse did not disassemble the foot switch to confirm the suspicion on what exactly caused the fluoroscopy pedal to stick to the mat.He replaced the foot switch (b)(4) with a newer type foot switch (b)(4) and scrapped the defective foot switch.Installing the new foot switch solved the reported issue, and the system was returned to the customer in working order.A philips complaint investigator and a system designer have investigated the reported issue and found that the patient received a total dose (total air kerma) of 2,32 gy during the procedure.The customer indicated that the fluoroscopy pedal got stuck for 4-5 minutes, giving the patient additional dose.Log file analysis shows that 5 minutes of additional fluoroscopy equites to a dose of 0,1 gy of the total dose of 2,32 gy.The 5 minutes of additional fluoroscopy did not cause the patient to receive more than 2 gy total dose which qualifies as a serious injury, but did however increase the total dose for the patient.Event log file analysis showed that the total dose (total air kerma) of 2,32 gy received by the patient was as expected when taking the patient thickness, chosen settings, number of cine frames and total fluoroscopy time into account.This leads to the conclusion that there is no indication that the intended dose of 2,22 gy was caused by a malfunction of the system.No further analysis on the defective footswitch can be performed since the fse scrapped the parts and no other evidence was available for investigation.We have not had any similar complaints in the last 3 years where a footswitch was stuck due to sticky substances.Conclusion of the analysis: the fse concluded that the fluoroscopy pedal was sticking to the mat due to a sticky substance like contrast.

• 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
• 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: 6193102
• MDR Text Key: 62955399
• Report Number: 3003768277-2016-00120
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

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: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: 12/13/2016
• Supplement Dates FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2006
• 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: 72 YR
• Patient Weight: 97