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

Model Number 722006

Device Problem Unintended Movement (3026)

Patient Problem Bruise/Contusion (1754)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that post procedure,while transferring the patient off the table, the table pivoted on its own.The patient suffered minor skin marks which were caused while the patient was caught by the medical staff.The patient did not fall.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips has confirmed with the customer that after completion of the procedure, the operator rolled the patient on her side.The patient rolled too far and started to slide off the table.In preventing the fall of the patient, the operator pushed against the table.The resulting push force was high and the table pivoted away slightly.The operator did not expect this unintended movement of the table.The philips ad7 table is designed to stay in place by means of a pivot brake, but also move when sufficient force is applied, so as not to injure hospital staff trying to move the table.Philips has inspected the system on site and it was identified that the friction force of the pivot brakes was approximately 20% lower than the minimal force required as per specifications, however braking force was available.The pivot brakes were adjusted and the system was returned to use in good working order.Analysis of the log files has also confirmed an unsolicited lateral movement of the table, confirming that the user pushed the table in the lateral direction with force, in order to prevent the patient from falling.Guidelines are described in the instructions for use (4522 203 17232) about table positioning (chapter 3.6.2) and patient positioning (chapter 3.6.4.) no similar complaints have been identified.Based on the investigation results, philips has concluded that the reported incident was caused due to the friction force of the pivot brakes that was below specifications and the user pushing the table laterally with force in order to prevent the patient from falling.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
• 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: 10301586
• MDR Text Key: 200596985
• Report Number: 3003768277-2020-00040
• 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: 06/27/2020

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: 722006
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 06/27/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 120