MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS MEDICAL SYSTEMS; ALLURA XPER FD10

Device Problems Mechanical Problem (1384); Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 09/20/2016

Event Type  malfunction  

Event Description

During procedure, a burning smell was first noticed and within moments a loud popping around occurred and the philips cath lab equipment shut off.It was also noticed the wall breaker had tripped.The procedure was aborted.

• Brand Name: PHILIPS MEDICAL SYSTEMS
• Type of Device: ALLURA XPER FD10
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS
• MDR Report Key: 6030216
• MDR Text Key: 57602002
• Report Number: MW5065379
• Device Sequence Number: 1
• Product Code: IZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR