MAUDE Adverse Event Report: PHILIPS BV 300; C-ARM/FLUROSCOPY

Model Number BV 300

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2015

Event Type  Injury  

Event Description

During the insertion of a pacemaker the fluoroscopy did not function after a second parallel wire was passed.Calls were made to the service reps by the radiology technician and the device was subsequently restarted and functioned.Pt status unchanged and remained stable after completion of the procedure.

• Brand Name: BV 300
• Type of Device: C-ARM/FLUROSCOPY
• Manufacturer (Section D): PHILIPS; andover MA 01810
• MDR Report Key: 4442811
• MDR Text Key: 5379802
• Report Number: MW5040325
• Device Sequence Number: 1
• Product Code: IZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BV 300
• Device Catalogue Number: 38583
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 78