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

Model Number 2170-3000A

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

The customer reported that, an operator had unpinned the imaging couch and was not able to pin it back into the sensor properly.The operator placed a service call for a philips field service engineer (fse) who evaluated and found the rear swivel pin (away from the gantry) was bout 1/4 to 3/8 inches in the hole.The philips fse noticed that the rear of the table was still elevated such that the rear wheels were off the ground but the system was still allowed all motions and studies to be performed.It was out enough that the pin could pivot around allowing the table to move away from the gantry as a result of which the locking pin would not go into its place.The operator informed the philips fse that it was possible that a patient transport cart may have caught under the brightview spect imaging couch and raised the imaging couch when they were raising the patient cart during a patient transfer.There was no patient on the imaging couch when the operator reported this event to philips.The philips fse re-pinned the imaging couch at the pivot point and confirmed proper operation of the imaging couch for the brightview spect camera.There was no harm to a patient or operator.

Manufacturer Narrative

(b)(4).Note: we have not completed our investigation of this event.We will file a follow-up 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: 3688105
• MDR Text Key: 4242220
• Report Number: 1525965-2014-00044
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2170-3000A
• Device Catalogue Number: 882480
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1