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

Model Number 722003

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Philips received a complaint from a customer that during the procedure the customer wanted to move the c-arm via the control panel the system was jerky.During the procedure the system moved differently from what the doctor had intended, the system ceased and then began to move on its own towards the patient.The table could not be moved.Through intervention of the doctors locally they prevented a collision of the c-arm with the patient.No patient, user or bystander was hit or injured.

Manufacturer Narrative

When investigation is completed a follow up report will be sent to fda.

Manufacturer Narrative

Philips investigated this complaint and found that this issue is caused by a problem with whitelisting resulting in a delay in the processing of geometry request (queue).If a movement of the c-arm is requested and a couple of requests stay in the queue they will be completed first when the next movement is requested.For the user this looks like the wrong movement is being performed.The ifu states to perform a system restart at least once a week.(b)(4).

Event Description

Philips received a complaint from a customer that during the procedure, the customer wanted to move the c-arm via the control panel, the system was jerky.During the procedure, the system moved differently from what the doctor had intended, the system ceased and then began to move on its own towards the patient.The table could not be moved.Through intervention of the doctors locally, they prevented a collision of the c-arm with the patient.No patient, user or bystander was hit or injured.

• 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 Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 4834940
• MDR Text Key: 18031815
• Report Number: 3003768277-2015-00046
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/15/2015

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: 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: 05/15/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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