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

Model Number 722026

Device Problems No Device Output (1435); Noise, Audible (3273)

Patient Problem Death (1802)

Event Date 05/30/2019

Event Type  Death  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

It has been reported to philips that during a procedure there was a noise coming from the tube while delivering x-ray.The procedure continued until x-ray was not available anymore.The patient was then transferred to another room where the patient died.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips has confirmed that a patient arrived with an acute phase myocardial infarction in order to undergo a revascularization by primary angioplasty on the philips x-ray system.Philips inspected the high voltage plug of the x-ray tube and concluded, based on the flash-over marks on the plug, that the cause of the noise and the arcing was a faulty high voltage (hv) plug connection.The hv plug was replaced and the system was returned to use in good working order.Philips has opened an investigation as a follow up for the noted complaint.Sex of the patient = male 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 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
• MDR Report Key: 8674388
• MDR Text Key: 147225401
• Report Number: 3003768277-2019-00047
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K031333
• 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: 05/31/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/06/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 90 YR
• Patient Weight: 70