MAUDE MDR 5461835

MDR report key
5461835
Report number
2183926-2016-00450
Event key
0
Event type
3
Date of event
2016-01-26
Date received
2016-02-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. MEG MUCHA
Address
900 WALNUT RIDGE DR HARTLAND WI 53029 US
Phone
262-262-2629
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MERGE EYE STATIONPICTURE ARCHIVING AND COMMUNICATIONS SYSTEMMERGE HEALTHCARENFJMERGE EYE STATION V11.1R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-250

Event Narratives#

N

Patient 1

MERGE HEALTHCARE MANUFACTURES MERGE EYE STATION SOFTWARE TO BE USED ON WORKSTATIONS MANUFACTURED BY (B)(4). MERGE HAS NOTIFIED (B)(4) OF THE ISSUE CAUSED BY THEIR FIELD TECHNICIAN. INVESTIGATION INTO THE DETAILS OF PATIENT DATA LOSS PER (B)(4): CUSTOMER ALLEGATION: 2 DRIVE RAID - CANNOT BOOT. RETURNED PRODUCT EVALUATION: BOTH DRIVES WERE INACCESSIBLE- EVEN THE ORIGINAL "GOOD" ONE. COULD NOT RECOVER ANY DATA. RESOLUTION: REPLACED BOTH DRIVES AND RELOADED WIN 7 AND EYESTATION 11.1 SW. -RETURNED TO CUSTOMER.

D

Patient 1

MERGE EYE STATION IS A COMPREHENSIVE SOFTWARE PLATFORM FOR THE IMPORT, INTEGRATION AND REVIEW OF PATIENT DATA AND CLINICAL INFORMATION IN AN EYE CARE ENVIRONMENT. MERGE EYE STATION ALLOWS FOR THE CAPTURE, COLLECTION, MANAGEMENT, ENHANCEMENT AND REVIEW OF THE PATIENT DEMOGRAPHICS, IMAGE DATA, DIAGNOSTIC DATA AND CLINICAL REPORTS FROM A VARIETY OF MEDICAL DEVICES THROUGH EITHER A DIRECT CONNECTION WITH THE INSTRUMENTS OR THROUGH COMPUTERIZED NETWORKS. CUSTOMER REPORTED A DRIVE FAILURE ON A TWO DISK MIRRORED RAID, ALSO KNOWN AS A RAID 1, ON A WINDOWS 7 WORKSTATION INSTALLED WITH MERGE EYE STATION. A RAID 1 CONSISTS OF AN EXACT COPY, OR MIRROR, OF A SET OF DATA ON TWO OR MORE DISKS. TYPICALLY A RAID 1 MIRRORED PAIR CONTAINS TWO DISKS. WHEN THE PRIMARY DRIVE FAILED, THE WORKSTATION CONTINUED FUNCTIONING WITH THE BACKUP, MIRRORED DRIVE AS EXPECTED. MERGE SUPPORT WORKED WITH THE HARDWARE MANUFACTURER OF THE PC, (B)(4), TO HAVE A TECHNICIAN FROM (B)(4) GO ONSITE TO REPLACE THE FAILED DRIVE. IT WAS EXPECTED OF (B)(4) TO INSERT A BLANK DRIVE INTO THE WORKSTATION SO THE MIRROR WOULD REBUILD AND THE WORKSTATION WOULD FUNCTION AS IT DID PRIOR TO THE PRIMARY HARD DRIVE FAILURE. ON (B)(6) 2016, THE (B)(4) TECHNICIAN ARRIVED ONSITE AND INSERTED A WINDOWS 7 HARD DRIVE INTO THE WORKSTATION, HOWEVER, THE DRIVE SHOULD NOT HAVE HAD AN OPERATING SYSTEM INSTALLED ON IT AS THE WORKSTATION WAS CONFIGURED WITH A MIRRORED RAID. ONCE THE NEW PRIMARY HARD DRIVE WAS INSTALLED WITH THE WINDOWS 7 OPERATING SYSTEM, THE RAID WAS REBUILT AND THE PRIMARY DISK OVERRODE WHAT WAS ON THE MIRRORED HARD DRIVE, ERASING THE MERGE EYE STATION APPLICATION, INCLUDING PATIENT DATA AND IMAGES. THIS LOSS OF PATIENT DATA HAS A POTENTIAL TO CAUSE A DELAY IN DIAGNOSIS OR TREATMENT. (B)(4).

N

Patient 1

MERGE HEALTHCARE MANUFACTURES MERGE EYE STATION SOFTWARE TO BE USED ON WORKSTATIONS MANUFACTURED BY (B)(4). MERGE HAS NOTIFIED (B)(4) OF THE ISSUE CAUSED BY THEIR FIELD TECHNICIAN. INVESTIGATION INTO THE DETAILS OF PATIENT DATA LOSS PER (B)(4): CUSTOMER ALLEGATION: 2 DRIVE RAID - CANNOT BOOT. RETURNED PRODUCT EVALUATION: BOTH DRIVES WERE INACCESSIBLE- EVEN THE ORIGINAL "GOOD" ONE. COULD NOT RECOVER ANY DATA. RESOLUTION: REPLACED BOTH DRIVES AND RELOADED (B)(4) AND EYESTATION (B)(4). -RETURNED TO CUSTOMER. FURTHER INVESTIGATION WAS PERFORMED AND IT WAS FOUND THAT THE IMAGES FOR ONE PATIENT WAS LOST AND THAT EXAM CONTAINED 36 IMAGES. THERE WERE NO PATIENTS/EXAMS THAT NEEDED TO BE RESCHEDULED BECAUSE OF THIS EVENT.

D

Patient 1

MERGE EYE STATION IS A COMPREHENSIVE SOFTWARE PLATFORM FOR THE IMPORT, INTEGRATION AND REVIEW OF PATIENT DATA AND CLINICAL INFORMATION IN AN EYE CARE ENVIRONMENT. MERGE EYE STATION ALLOWS FOR THE CAPTURE, COLLECTION, MANAGEMENT, ENHANCEMENT AND REVIEW OF THE PATIENT DEMOGRAPHICS, IMAGE DATA, DIAGNOSTIC DATA AND CLINICAL REPORTS FROM A VARIETY OF MEDICAL DEVICES THROUGH EITHER A DIRECT CONNECTION WITH THE INSTRUMENTS OR THROUGH COMPUTERIZED NETWORKS. CUSTOMER REPORTED A DRIVE FAILURE ON A TWO DISK MIRRORED RAID, ALSO KNOWN AS A RAID 1, ON A WINDOWS 7 WORKSTATION INSTALLED WITH MERGE EYE STATION. A RAID 1 CONSISTS OF AN EXACT COPY, OR MIRROR, OF A SET OF DATA ON TWO OR MORE DISKS. TYPICALLY A RAID 1 MIRRORED PAIR CONTAINS TWO DISKS. WHEN THE PRIMARY DRIVE FAILED, THE WORKSTATION CONTINUED FUNCTIONING WITH THE BACKUP, MIRRORED DRIVE AS EXPECTED. MERGE SUPPORT WORKED WITH THE HARDWARE MANUFACTURER OF THE PC, (B)(4), TO HAVE A TECHNICIAN FROM (B)(4) GO ONSITE TO REPLACE THE FAILED DRIVE. IT WAS EXPECTED OF (B)(4) TO INSERT A BLANK DRIVE INTO THE WORKSTATION SO THE MIRROR WOULD REBUILD AND THE WORKSTATION WOULD FUNCTION AS IT DID PRIOR TO THE PRIMARY HARD DRIVE FAILURE. ON 1/29/2016, THE (B)(4) TECHNICIAN ARRIVED ONSITE AND INSERTED A (B)(4) HARD DRIVE INTO THE WORKSTATION, HOWEVER, THE DRIVE SHOULD NOT HAVE HAD AN OPERATING SYSTEM INSTALLED ON IT AS THE WORKSTATION WAS CONFIGURED WITH A MIRRORED RAID. ONCE THE NEW PRIMARY HARD DRIVE WAS INSTALLED WITH THE (B)(4) OPERATING SYSTEM, THE RAID WAS REBUILT AND THE PRIMARY DISK OVERRODE WHAT WAS ON THE MIRRORED HARD DRIVE, ERASING THE MERGE EYE STATION APPLICATION, INCLUDING PATIENT DATA AND IMAGES. THIS LOSS OF PATIENT DATA HAS A POTENTIAL TO CAUSE A DELAY IN DIAGNOSIS OR TREATMENT. (B)(4).