MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10

Model Number 722010

Device Problems Device Stops Intermittently (1599); Inappropriate or Unexpected Reset (2959)

Patient Problem Death (1802)

Event Date 12/28/2013

Event Type  Death  

Event Description

Philips received a report from a customer that there is an intermittent collimator problem (diaphragm).The hospital had the problem multiple times and they could reinitialize the system the reboot of the system caused time loss of the procedure.The pt died but the customer stated that it was not directly related to the machine.The pt died before the procedure.

Manufacturer Narrative

(b)(4).When investigation is completed a follow up report will be sent to the fda.

• Brand Name: ALLURA XPER FD10
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer Contact: dominic siewko ; 3000 minuteman road; ms 4-135; andover, MA 01810 ; 9786597936
• MDR Report Key: 3565113
• MDR Text Key: 15203492
• Report Number: 3003768277-2014-00002
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2013

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: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death