MAUDE Adverse Event Report: PHILIPS MEDICAL PHILIPS MEDICAL; NUCLEAR MEDICINE GAMMA CAMERA

Model Number FORTE

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

Patient Problem No Information (3190)

Event Date 01/12/2016

Event Type  Injury  

Event Description

During a routine service performance, it was noted that movement on radius detector 2 was abnormal resulting in rough/loud movement.System was taken out of service at this time so no injury to patient or staff occurred.Further investigation indicated ball screw bearing/ball screw actuation causing the anomaly.The replacement of these components rectified the issue and the device was turned back over for patient use.The original equipment mfr ((b)(4)) completed the ball screw/bearing replacement on (b)(6) 2016.The unit has been operating within all specs since the repair.

• Brand Name: PHILIPS MEDICAL
• Type of Device: NUCLEAR MEDICINE GAMMA CAMERA
• Manufacturer (Section D): PHILIPS MEDICAL; cleveland OH
• MDR Report Key: 5537502
• MDR Text Key: 41647624
• Report Number: MW5061357
• Device Sequence Number: 1
• Product Code: IYX
• 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: 03/28/2016

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: FORTE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention