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

Model Number 722026

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 10/05/2016

Event Type  Death  

Manufacturer Narrative

When the investigation has been completed, philips will inform the fda.(b)(4).

Event Description

Philips received a complaint from the customer in which was stated that during the procedure, the system got shutdown automatically and no geometry movement was available.The customer decided to transport the patient to another location, the patient died during this transport.The system showed a message "no connection to host pc".

Manufacturer Narrative

A philips field service engineer (fse) went on site ((b)(6) 2016) to troubleshoot the issue.He found that the host pc failed because of a hardware issue.This caused the system to shut down automatically with no geometry movement possible and explains why the table side module gave a message ¿no connection to host¿.Replacing the host pc solved the issue the customer reported.Nce (non conformance evaluation) was raised to investigate the issue.Hereby a summary of this evaluation: the cause of the issue was identified to be the host pc.Preliminary investigation from the supplier revealed that the psu (power supply unit) within the host pc caused the host pc to fail.A further investigation at the subsystem supplier was started to determine why the psu failed.The outcome of this investigation was: date (b)(6) 2017 subsystem supplier statement ¿power supply failed due to an overload on the 12v power line.There is no overcurrent protection on this line.The power supply had more than 0.8a being drawn from the 12v supply line.Overcurrent on the 12v line will cause the power supply to fail.Per date code ((b)(6) 2017 ) the power supply has been made around 3~4 years ago.After we checked our return material authorization record we could not find a failure of this part in the past.The 12v line does not have an over voltage protection.If the system would draw more current than the specification will allow (0.8a) the power supply will fail.Since this is the only one case we have found we infer that this is caused by a random component failure or 12v current was drawing more than designed (0.8a)¿.

• 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 (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: 6010684
• MDR Text Key: 56791184
• Report Number: 3003768277-2016-00094
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 722026
• Device Catalogue Number: 722026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: 10/05/2016
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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
• Patient Age: 55 YR
• Patient Weight: 67