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

Model Number NMH801

Device Problems Break (1069); Unintended Collision (1429); Unintended Movement (3026)

Patient Problem Bruise/Contusion (1754)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.

Event Description

The customer reported that the patient table was positioned lengthwise in the radial axis of detectors.The pre-programmed "patient release" motion was initiated and the detector contacted the patient's head prior to the patient being manually removed.The detector then continued movement until it contacted the table; damaging the detector cover.The patient was sent to the er for a ct scan which revealed bruising, but no broken bones.

Manufacturer Narrative

Investigation revealed the patient injury occurred as a result of multiple use errors: 1.The operator performed a scan with the patient table located in an unapproved position, not in front of the gantry.2.The operator did not follow the instructions to monitor the position of the patient and equipment during scan procedures.In addition, clearance area was not marked on the floor.Existence of such marking would enable the operator to notice that the table is within the gantry area where detectors are rolling.The costumer refused (during installation) to set the yellow marks on the floor.

• Brand Name: MILLENNIUM MG
• Type of Device: TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; tirat hacarmel; haifa ; IS
• Manufacturer (Section G): GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; tirat hacarmel; haifa ; IS
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy.; barrington, IL 60010
• MDR Report Key: 5104880
• MDR Text Key: 26959447
• Report Number: 9613299-2015-00009
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• PMA/PMN Number: K962738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NMH801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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