MAUDE Adverse Event Report: PHILIPS HEALTHCARE BV ENDURA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 718074

Device Problems Break (1069); Self-Activation or Keying (1557)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  malfunction  

Manufacturer Narrative

It was the cable closest to the pedal that was damaged.When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which it was stated that c-arm takes a lot of images by itself when it's not intended.Personnel who would assist in the narcosis did not wear protective clothing against radiation and were exposed.Occurs in the midst of the narcosis and staff without protective clothes could not go out.Happened on two occasions.The c-arm started to expose without anyone touching the pedal.The technicians found the error and corrected this.It was the cable closest to the pedal that was damaged.No patient or user harm has been reported as the system was not in clinical use there was no object between the x-ray beam and the detector, therefore there was no radiation scattering.

Manufacturer Narrative

Philips investigated this complaint about unintended irradiation that took place on a bv endura system.The device was not in clinical use and no patient or user harm has been reported.A philips system specialist analyzed the problem and came to the following conclusion: when the x-ray was generated and no patient or object was within the x-ray beam the system would regulate to approx.45kv.Also with no object, the scatter radiation will be very low.The dose received by the personnel will be very low.So low, that is even not possible to measure.Fse visited the site and confirmed the issue and observed that footswitch went defective.This caused unintended radiation as reported by the user.The replacement of the faulty footswitch with a new footswitch resolved the issue.Based on the fse communication, we understand that footswitch cable was damaged which in turn caused this issue.It is seen as more of a handling issue of the footswitch.As per service history the footswitch was with machine since 2015 and eventually went defective in 2017.Hence this is seen as normal wear and tear the part is categorized as non repairable item and hence not available for investigation.The replacement rate for this footswitch in 2017 (including the cable) is 9.86 % and is well under the upper control limit of 13 %.Conclusion of the analysis: damaged footswitch cable caused the issue of unintended radiation from the system.The life of the footswitch depends on the how it is handled by user.The replacement of faulty footswitch with a new footswitch resolved the issue.

• Brand Name: BV ENDURA
• 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
• 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: 6669513
• MDR Text Key: 78675854
• Report Number: 3003768277-2017-00061
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K010435
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 718074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 06/13/2017
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2007
• 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