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 No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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 the c-arm x-rayed by itself without anyone touching the foot switch.The operator discovered this and the nurse had to use the emergency stop to end the exposure.The nurse used another system to continue the examination.Technicians found the fault and rectified it.It was the cable close to the foot switch that was damaged.No patient or user harm was reported by the customer.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: the analysis concluded that footswitch cable was damaged which lead to this issue.It is susceptible to experience various stretch/strain forces during operation can damage the footswitch cable and can lead to this failure.Exact cause of the damage of the footswitch cable is not known as the defective footswitch is scrapped locally by the customer hospital technician had replaced the footswitch to resolve the issue for the customer.Customer is not having service contract with philips and they do maintenance by themselves.Actual footswitch and cable were scrapped by the customer.

• 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: 6409382
• MDR Text Key: 70131154
• Report Number: 3003768277-2017-00032
• 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: 03/07/2017

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: 03/07/2017
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2007
• 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