MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRIGHTVIEW GAMMA CAMERA SYSTEM

Model Number 882480

Device Problem Mechanical Problem (1384)

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

Event Type  No Answer Provided  

Event Description

In this case, the operator had finished acquiring a hepatobiliary iminodiacetic acid (hida) scan on the brightview spect camera for a pt who (b)(6).The operator executed the "pt load" pre-programmed motion (ppm) to remove the pt from the system.While the imaging pallet was retracting onto the imaging couch, the imaging couch began to lower while the imaging pallet was partly on the lifter.The imaging pallet began to bind and the operator activated an emergency stop button to halt the system motion in a controlled fashion.The operator was able to remove the pt from the imaging pallet.A philips service engineer evaluated and found that the bushing screwed into the drive gear had failed from the drive block when the imaging pallet was retracting onto the imaging couch.There was no harm to the pt.

Manufacturer Narrative

(b)(4).We will file a f/u mdr at the completion of the investigation.(b)(4).

• Brand Name: BRIGHTVIEW GAMMA CAMERA SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: kumudini carter ; 595 miner rd; cleveland, OH 44143 ; 4404833032
• MDR Report Key: 3769659
• MDR Text Key: 4437024
• Report Number: 1525965-2014-00075
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 882480
• Device Catalogue Number: 2170-3000A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1