FDA Adverse Event Malfunction Summary report: N

PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS)

MDR report key: 5737782 · Received June 21, 2016

Report

Report Number
5737782
Event Type
Malfunction
Date Received
June 21, 2016
Date of Event
May 3, 2016
Report Date
June 7, 2016
Manufacturer
MCKESSON MEDICAL IMAGING COMPANY
Product Code
LLZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE STEREOTACTIC IMAGING ON THE CDS WAS NOT WORKING. REQUIRED A TOTAL OF 3 DISCS WITH IMAGING TO BE RETRIEVED, WHILE THE PATIENT WAS UNDER ANESTHESIA (APPROX. 14 HOURS). THIS IS WHAT THE PATIENT SAFETY REPORT STATED: PA WAS ATTEMPTING TO BRING UP THE STEREOTACTIC IMAGE ON DISC ON THE STRYKER UNIT PRIOR TO DR BEGINNING SURGERY. THE DISC WOULD NOT FUNCTION OR OPEN THE IMAGE. THE PATIENT WAS UNDER ANESTHESIA AT THIS POINT WITHOUT AVAILABLE IMAGE. PA CALLED THE FILE ROOM. THE CD BURNER WAS NOT WORKING. HE WAS CONNECTED TO MEDICAL RECORD DEPARTMENT WHO BURNT A DISC FOR HIM. ONCE BACK IN THE OPERATING ROOM, IT WAS REALIZED THAT THE SECOND DISC HAD THE INCORRECT IMAGE BURNT ON IT. WHILE PA WAS RETRIEVING THE 3RD DISC FROM MEDICAL RECORDS, THE STRYKER REP MADE AVAILABLE A SECOND STRYKER UNIT. PRIOR TO PA RETURNING TO OPERATING ROOM WITH A THIRD DISC, THE FIRST DISC WAS ABLE TO BE UTILIZED TO OPEN THE IMAGE ON THE SECOND STRYKER UNIT. DR WAS ABLE TO BEGIN THE SURGERY. IT IS REPORTED THAT ONCE SURGERY BEGAN, THE PATIENT HAD BEEN UNDER ANESTHESIA WITHOUT ANY SURGICAL INTERVENTION FOR APPROXIMATELY ONE HOUR. IT WAS LATER LEARNED THAT THE DISC DRIVE IN THE FIRST STRYKER UNIT WAS DYSFUNCTIONAL. IT IS POSSIBLE THAT IF THE DISC DRIVE WERE TO HAVE WORKED IN THE FIRST STRYKER UNIT, THAT THE FIRST DISC MAY HAVE OPENED THE IMAGE. OVERALL, THREE CONCERNS: THE NON FUNCTIONING DISC DRIVE IN THE STRYKER UNIT. THE INABILITY TO BEGIN SURGICAL INTERVENTION WHILE THE PATIENT IS UNDER ANESTHESIA. AN INABILITY TO UTILIZE THE PAC SYSTEM TO OPEN IMAGE, REQUIRING THE IMAGE TO BE BURNT ON A DISC (ACKNOWLEDGING THIS IS NOT A NEW PROCESS). IT IS REPORTED THAT IT IS NOT UNCOMMON THAT THE INITIAL DISC BROUGHT TO THE OPERATING ROOM IS NOT FUNCTIONAL FOR VARIOUS REASONS AND A SECOND DISC HAS TO BE RETRIEVED DURING OR CASES. THE STRYKER IMAGING REP WAS PRESENT FOR THE CASE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
394191 PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS) SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ MCKESSON MEDICAL IMAGING COMPANY

Patients

Seq Age Sex Outcome Treatment
1 58 YR OTHER, POSSIBLY ANESTHESIA