MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY VCT; TOMOGRAPHY, COMPUTED, EMISSION

Model Number PSEVCT

Device Problem Mechanical Problem (1384)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

The scan window (p/n 5332239) was evaluated by the fe with no defects or issues found.When the patient pushed on the window with extraordinary force, the window deflected enough such that it caught on the rotating side.The gantry design includes requirements for mechanical strength to satisfy requirements for enclosures.The design for ct system complies with appropriate standards.The gantry scan window shall not come in contact with the rotating components when the patient or operator presses against them with a force of up to 1,453 lb/ft^2 or 45 n/in^2 per iec 60601-1:1988 clause 21.Note: it is assessed that the push force test of 45 n force applied over an area of 625 mm^2 (i.E.1 in^2), as required by the second edition of iec 60601-1 is acceptable.The gantry scan window shall not come in contact with the rotating components when the patient or operator presses against them with a force of mechanical strength in accordance with iec 15.3.2.

Event Description

It was reported that during scan, a panicked patient's knee penetrated the mylar scan window and contacted the rotating collimator, resulting in a fracture.The scan window came apart from the gantry.

• Brand Name: DISCOVERY VCT
• Type of Device: TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI
• Manufacturer Contact: jason kelly ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 6409671
• MDR Text Key: 70107222
• Report Number: 2126677-2017-00002
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K050559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PSEVCT
• Other Device ID Number: UDI_NOT_REQUIRED
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Weight: 60