MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING INFINIA HAWKEYE; TOMOGRAPHY, COMPUTED, EMISSION

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/06/2014

Event Type  Injury  

Event Description

It was reported that a pt was positioned with her arms protruding from the sides of the table, and a chair was placed within the detector's operation area.As part of the automatic unload sequence initiated by the operator, while the detectors were rotating, the pt's hand was trapped between the side of the detector and the chair.As a result the pt's hand was "squeezed," and the pt suffered of five broken bones on her hand requiring a cast.

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.

• Brand Name: INFINIA HAWKEYE
• Type of Device: TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; tirat hacarmel ; IS
• Manufacturer (Section G): GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; tirat hacarmel ; IS
• Manufacturer Contact: paul corrigan ; 3000 n. grandview blvd; waukesha, WI 53188 ; 4142130021
• MDR Report Key: 4092453
• MDR Text Key: 4717164
• Report Number: 9613299-2014-00004
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K052434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2014
• Initial Date FDA Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2007
• 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; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 80