MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10/10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722005

Device Problem Failure to Shut Off (2939)

Patient Problem Radiation Overdose (1510)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported to philips that during a procedure the system continued to perform fluoroscopy even after the user removed the foot off the footswitch.Additionally, the patient received a high dose.The procedure was completed successfully.No harm to the patient has been reported to philips.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The reported problem occurred during a diagnostic clinical procedure.The procedure was completed successfully after a warm restart.The system functioned as intended for the remaining procedures on the date of occurrence ((b)(6) 2020).Philips inspected the system on site, and based on the troubleshooting, no malfunction of the system could be confirmed.The footswitch of the system was replaced proactively, after which the system was returned to use in good working order.The dose report for the date of the procedure ((b)(6) 2020) was no longer available on the system.Therefore, the exact unintended dose could not be determined.Philips analyzed the log files of the system and estimated that the amount of unintended dose the patient may have received to be approximately 4mgy.Our evaluation concluded that the incident did not pose risk to health to patients, users, did not allege a serious injury or death and would not cause or contribute to a serious injury or death if the reported issue recurred.The design of the footswitch (12nc: 989601040082) is robust to unintended activation due to mechanical failure.However, unintended activation of the footswitch due to it being pressed by a desk chair or other equipment in the control room or examination room cannot be ruled out.Philips has not been able to confirm the exact cause of this occurrence.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 FD10/10
• 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
• MDR Report Key: 10085171
• MDR Text Key: 193418844
• Report Number: 3003768277-2020-00025
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• 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: 02/04/2020

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: 722005
• Device Catalogue Number: 722005
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/25/2020
• Supplement Dates Manufacturer Received: 04/30/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 74