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

Model Number 722035

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Overdose (1988)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up will sent to the fda contact office address (b)(4).

Event Description

Philips received a complaint from the customer in which they stated that a patient was harmed due to receiving a higher dose than necessary.Philips is in the process of acquiring more detailed information from the customer.

Manufacturer Narrative

A philips service engineer went on site but was unable to obtain log files to troubleshoot the issue.Due to the nature of the error no dose report was available, but the customer confirmed that there was no harm to the patient the philips service engineer was unable to replicate the reported issue on the system and could not find anything out of the ordinary.Since we could not replicate the issue and no log files are available, we see this issue as a one time occurrence.(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 Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 5185063
• MDR Text Key: 29778104
• Report Number: 3003768277-2015-00092
• Device Sequence Number: 1
• Product Code: OBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133239
• 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: 09/29/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• 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: 09/29/2015
• 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): Other