MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20 OR TABLE; ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER

Model Number 722035

Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problem Death (1802)

Event Date 02/04/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).When the investigation is completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which they stated that a patient died after surgery.After the procedure was finished the patient needed to be tilted head down to recover from anesthesia the table could not be moved because e-stop was accidently activated by the staff and no one noticed.At this moment it's still unclear if this caused the death of the patient.As this is a hybrid system the table can used as standalone device for surgery, the allura system was not used for this procedure.

Manufacturer Narrative

A philips service engineer checked the log files and found that a staff member activated the emergency stop on the allura system which locked the table, making it impossible to move the table into the trendelenburg position.Since there was no need for the allura system except for the flex vision monitor which was displaying the patents¿ vitals, there was only operating room staff in the room and no cath lab or radiology staff.As confirmed by the customer, the or staff only had minimal participation in the handover training and was unable to reset the stop signal.Usually in surgery only cases the allura system is kept off and the maquet table functions independently from it.When the allura system is kept off the emergency stop buttons on the mcs and tso are nonfunctional.The staff supervisors have been informed with a demonstration how to use the maquet table after the incident.The hospital has taken the action to have at least one trained member of personnel available in the room when used during medical procedures.According the hospital staff the system did not contribute to the death of the patient.(b)(4).

• Brand Name: ALLURA XPER FD20 OR TABLE
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER
• 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: 5473350
• MDR Text Key: 39440043
• Report Number: 3003768277-2016-00022
• Device Sequence Number: 1
• Product Code: OBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141979
• 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: 02/05/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722035
• Device Catalogue Number: 722035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death