MAUDE Adverse Event Report: GENERAL ELECTRIC CENTRICITY; MDDS PACS

Device Problem Data Problem (3196)

Patient Problem No Information (3190)

Event Date 06/23/2014

Event Type  Injury  

Event Description

A critically ill pt under went radiographic eval of chest and abdomen.The last name of the pt contained one apostrophe.The radiograph images could not be accessed on the ehr results mdds.It was determined that the one entering the pt's name at the imaging vendor entered a double apostrophe, rather than one.It could not be corrected for days, once the images were found, 5 days after they were done.It took another 3 days for pacs vendor to correct this misidentification issue.The vendor's device is defective because it allowed absurdity (there is never a name with consecutive apostrophes) and it failed to warn of the error.These mdds devices need tighter regulation, surveillance, and safety.

• Brand Name: CENTRICITY
• Type of Device: MDDS PACS
• Manufacturer (Section D): GENERAL ELECTRIC; fairfield 06828
• MDR Report Key: 3913670
• MDR Text Key: 4587611
• Report Number: MW5037054
• Device Sequence Number: 1
• Product Code: OUG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2014

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?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2014
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 76