MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 1.5T SIGNA HDX MR SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

Patient information could not be provided due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare's investigation is ongoing.A follow up-report will be submitted once the investigation has been completed.

Event Description

During an examination, a patient with dementia was positioned on the table and secured with the wide table strap in place to assure that the patient did not fall.The patient crawled out of the magnet bore and off of the table without the technologist noticing.The patient complained of pain in their left foot so x-rays were taken but no abnormalities were found.Several days later the patient continued to complain of pain, so more x-rays were taken and a fracture was detected.

Manufacturer Narrative

Ge healthcare's investigation found this complaint to be the result of inadequate patient monitoring for a patient where reliable communication cannot be maintained.It was recommended the customer review the section of the hdxt operation manual that concerns the need to closely monitor high risk patients.A ge healthcare service representative confirmed the customer understood it is their responsibility to carefully monitor high risk patients.

• Brand Name: GE 1.5T SIGNA HDX MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n. grandview blvd.; waukesha WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3200 n. grandview blvd.; waukesha WI 53188
• Manufacturer Contact: brad wheeler ; 3000 n. grandview blvd., w450; waukesha, WI 53188 ; 2625443347
• MDR Report Key: 5689728
• MDR Text Key: 46256376
• Report Number: 2183553-2016-00011
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K052293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2007
• 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