FDA Adverse Event Malfunction Summary report: N

ISITE PICTURE ARCHIVING & COMMUNICATION SYSTEM

MDR report key: 1781517 · Received July 22, 2010

Report

Report Number
MW5016849
Event Type
Malfunction
Date Received
July 22, 2010
Date of Event
June 2, 2010
Report Date
July 14, 2010
Manufacturer
PHILIPS
Product Code
LLZ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

INSTANCE 1: ON (B)(6) 2010, A RADIOLOGIST WAS USING POWERSCRIBE TO DICTATE A SERIES OF REPORTS FOR A LIST OF PTS "OPENED" IN ISITE WHEN THE WORKSTATION "CRASHED" FOR UNK REASONS. SUCH CRASHES ARE NOT INFREQUENT. FOLLOWING REBOOTING OF THE WORKSTATION, ALL THE PTS WERE "LOCKED" IN ISITE (AS IS TYPICAL FOLLOWING A CRASH) AND WERE THEN UNLOCKED BY THE ADMINISTRATOR. SHORTLY THEREAFTER, THE RADIOLOGIST OPENED A PREVIOUSLY DICTATED PT AND DISCOVERED A MISMATCH: THE POWERSCRIBE REPORT TEXT AGREED WITH THE IMAGES AND THE IDENTIFIERS DISPLAYED IN ISITE BUT IT DID NOT AGREE WITH THE NAME DISPLAYED IN THE POWERSCRIBE PT NAME FIELD. THE POWERSCRIBE PT NAME FIELD INDICATED A DIFFERENT PT, ONE WHOSE DICTATION HAD BEEN PERFORMED EARLIER IN THE DAY. THE RADIOLOGIST LOGGED OUT OF POWERSCRIBE AND ISITE, LOGGED BACK IN TO BOTH, AND SAW THE THIS MISMATCH PERSISTED. THE WORKSTATION WAS THEN REBOOTED, THOUGH IT OTHERWISE APPEARED TO BE FUNCTIONING NORMALLY, AND THE MISMATCH WAS NO LONGER SEEN. INSTANCE 2: ON THE FOLLOWING DATE, A RADIOLOGIST DICTATED A REPORT WITH NO MORE THAN SIX PTS "OPENED" IN ISITE. THIS WAS DONE ON A DIFFERENT WORKSTATION THAT IN INSTANCE 1, ABOVE. HE SAVED THE REPORT (USING THE "SAVE" BUTTON), DID NOT SIGN THE REPORT, AND SUBSEQUENTLY DISCOVERED THE DICTATION UNDER A DIFFERENT PT'S NAME AS HE BEGAN TO REVIEW THIS DIFFERENT PT'S IMAGES. THE DIFFERENT PT SHOULD HAVE HAD NO DICTATION AT ALL. ADDITIONALLY, NO DICTATION WAS PRESENT UNDER THE PROPER PT'S NAME. THIS INSTANCE, UNLIKE THE FIRST, INVOLVED NO WORKSTATION CRASH OR REBOOTING. HAD THESE MISMATCHES OF PT'S NAMES NOT BEEN DETECTED BY THE RADIOLOGIST, WRONG-NAME REPORTS WOULD HAVE BEEN GENERATED. BECAUSE THESE INSTANCES REPRESENT SIGNIFICANT POTENTIAL PT SAFETY ISSUES, BOTH POWERSCRIBE (DICTAPHONE) AND ISITE (PHILIPS) WERE NOTIFIED AND ENGAGED PROMPTLY. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DICTATION. PACS SYSTEM IS PHILIPS ISITE VERSION (B)(4) DICTATION SOFTWARE IS NUANCE HEALTHCARE'S POWERSCRIBE V.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ISITE PICTURE ARCHIVING & COMMUNICATION SYSTEM PICTURE ARCHIVING LLZ PHILIPS
2 POWER SCRIBE DICTATION SYSTEM COMMUNICATION SYSTEM LLZ NUANCE HEALTH CARE

Patients

Seq Age Sex Outcome Treatment
1 Other NUANCE HEALTHCARE'S POWERSCRIBE