MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. FORTE GAMMA CAMERA JETSTREAM; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number 882320

Device Problem Mechanical Problem (1384)

Patient Problem Physical Entrapment (2327)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

The patient was undergoing a scan with this device.At the conclusion of the scan, the staff operating the machine attempted to remove the patient from the machine (cameras retract and bed moves out).The device stopped moving with the position of the camera and bed trapping the patient within the machine for approximately 30 min.Staff were eventually able to find a manual way to release the table and retract the patient from the machine.There was no harm to patient, only inconvenience.This device has had at least one other similar incident.

• Brand Name: FORTE GAMMA CAMERA JETSTREAM
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner road; cleveland OH 44143
• MDR Report Key: 4717869
• MDR Text Key: 22055499
• Report Number: 4717869
• Device Sequence Number: 1
• Product Code: KPS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 882320
• Device Catalogue Number: 882320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2015
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR