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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMO PROGRAMMABLE DIAGNOSTIC COMPUTER

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MERGE HEALTHCARE MERGE HEMO PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number MERGE HEMO V10.0.1
Device Problem Device Operational Issue (2914)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2016
Event Type  malfunction  
Manufacturer Narrative
Merge healthcare conducted an internal quality investigation to address the issue reported in recall 2183926-02/15/2016-031-c, fda recall number z-0665-2017. Merge healthcare received reports of the hemo monitor application unexpectedly stopping to display and update patient data. When this issue occurs, the hemodynamics system is no longer capturing patient data. For customers who experience this issue, it is recommended that the hemo monitor pc is power cycled. Once the system is powered up, the hemo application should restart with normal functionality and will once again display, update and record patient data. The restarting of the hemo monitor pc may result 0630 in a delay of up to two minutes while the system reboots. The investigation and troubleshooting activities conducted by merge healthcare found that the issue occurred due to an error when interfacing with a specific location within a schiller pdm (patient data module) file. Merge has validated and released a firmware fix for this issue. This fix is incorporated into the software upgrade of merge hemo 9. 40. 3 patch 1 (or later), or merge hemo 10. 0. 3 patch 1 (or later). The correction has been verified to be effective as is evidenced through the large reduction of customer complaints concerning this issue. Revised information contained in this supplemental report includes the following: updated contact office: name/address. Date new information received by manufacturer (planned implementation date). Indication that this is follow-up report 1. Indication of malfunction as reportable event. Indication of additional information and device evaluation. Indication that device evaluated by manufacturer. Software evaluation. Design error [the device or component had faulty (incomplete or incorrect) software design]. Design deficiency [the device problem was traced back to the design specifications (e. G. In the requirements, testing processes, hazard analysis, implementation strategy]. Addition of fda assigned recall reporting number. Indication of additional manufacturer information is contained in this follow-up report.
 
Event Description
Merge hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure. During a cardiac catheterization procedure, all three monitor screens went black and the patient data module (pdm) emitted a beeping tone. The site rebooted the hemo pc multiple times in order to load the windows 7 operating system. Once the user was able to log into windows, merge healthcare's support technician remotely connected to the hemo pc and created a shortcut in the startup for the hemo monitor application in order to get the merge hemo application functioning again. Once that was complete, the procedure resumed and was completed. There was a patient on the table and the procedure was delayed by 35 minutes. With merge hemo not presenting physiologic data during a cardiac catherization procedure, there is a potential for a delay in care that results in harm to the patient. The customer did confirm that the procedure completed successfully and there was no harm to the patient. Following this event, the customer requested that the operating system and merge hemo application be reinstalled on the pc. A technician was sent on site on 1/22/2016 to reinstall the operating system and merge hemo application.
 
Manufacturer Narrative
The patient that was on the table when this event occurred was not harmed, however, additional sedation had to be administered due to the delay. The patient's demographs is unknown.
 
Event Description
Merge hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure. During a cardiac catheterization procedure, all three monitor screens went black and the patient data module (pdm) emitted a beeping tone. The site rebooted the hemo pc multiple times in order to load the (b)(4) operating system. Once the user was able to log into windows, merge healthcare's support technician remotely connected to the hemo pc and created a shortcut in the startup for the hemo monitor application in order to get the merge hemo application functioning again. Once that was complete, the procedure resumed and was completed. There was a patient on the table and the procedure was delayed by 35 minutes. With merge hemo not presenting physiologic data during a cardiac catheterization procedure, there is a potential for a delay in care that results in harm to the patient. The customer did confirm that the procedure completed successfully and there was no harm to the patient. Following this event, the customer requested that the operating system and merge hemo application be reinstalled on the pc. A technician was sent on site on (b)(4) 2016 to reinstall the operating system and merge hemo application. (b)(4).
 
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Brand NameMERGE HEMO
Type of DevicePROGRAMMABLE DIAGNOSTIC COMPUTER
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
MDR Report Key5450584
MDR Text Key282116343
Report Number2183926-2016-00445
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
PMA/PMN Number
K082421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 01/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMO V10.0.1
Device Catalogue Number10.0.1
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received06/30/2017
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0665-2017

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