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

Model Number 722012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Irritation (2076); Skin Inflammation (2443)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It has been reported to philips that a patient suffered from blisters on his back after two sequent procedures.The patient reported an appearance one week after the operation on (b)(6).Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The customer reported to philips that the patient suffered from suspected radiation burn on his back.Philips was informed that the patient had a pre-existing condition of hepatitis b, liver cirrhosis, liver cancer.However, the customer has not provided the requested additional information regarding the reported incident and the patient outcome despite good faith effort performed by philips.The customer did not allow onsite inspection of the system by philips.System log files and dose reports were also not provided by the customer.Based on the limited information available, philips has not been able to identify or confirm the root cause of the issue.The customer stated that the philips system did not malfunction.Based on this statement of the customer, philips has closed this complaint.Correction of initial report text in section b5, section h6, method code was changed as the device was not available for investigation.Section d2 common device name was corrected to interventional fluoroscopic x ray system.Section e1 address has been changed.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.H3 other text : the customer did not allow onsite inspection of the system by philips.System log files and dose reports were also not provided by the customer.

Event Description

It has been reported to philips that a patient suffered from blisters on his back after two consecutive procedures.The patient reported the appearance of the blisters one week after the operation on 14 february.Philips has started an investigation for this complaint.

• 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: 9865749
• MDR Text Key: 184498664
• Report Number: 3003768277-2020-00016
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059054
• UDI-Public: (01)00884838059054
• Combination Product (y/n): N
• PMA/PMN Number: K130638
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 722012
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 70