MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; PEDAL, FLUOROSCOPY

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2017

Event Type  malfunction  

Event Description

Fluoroscopy machine in the bi-plane was not working during a procedure.Upon investigation it appeared that the physician was tapping fluoro pedal.It was tested and the physician was not tapping his foot and the imaging "flicker" was attributed to the pedal.Manufacturer response for fluoroscopy pedal, (brand not provided) (per site reporter): unknown - they were on site to look at the machine.They are replacing the part and have spoken with bio-med department.

Event Description

Fluoroscopy machine in the bi-plane was not working during a procedure.Upon investigation it appeared that the physician was tapping floro pedal.It was tested and the physician was not tapping his foot and the imaging "flicker" was attributed to the pedal.Manufacturer response for fluoroscopy pedal, (brand not provided) (per site reporter): unknown - they were on site to look at the machine.They are replacing the part and have spoken with bio-med department.

• Type of Device: PEDAL, FLUOROSCOPY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 595 miner road; cleveland OH 44143
• MDR Report Key: 6331452
• MDR Text Key: 67451560
• Report Number: 6331452
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

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: Physician
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MULTIPLE; MULTIPLE