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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1
Device Problems Communication or Transmission Problem (2896); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/26/2018
Event Type  malfunction  
Manufacturer Narrative
Troubleshooting efforts between the customer and merge technical support confirmed that the green led lights for 5/12 v were both lit on the link assembly. It was also confirmed that all cabling was correctly connected. Merge technical support then advised the customer to reboot the hemo system. The customer was shipped replacement hardware (pdm) on 26jan2018 ((b)(4)). The faulty unit was sent to the manufacturer for evaluation and received by merge healthcare on 06feb2018. The manufacturer's evaluation results found that the customer's reported problem, unit buzzing, could not be duplicated. However, the pump was found to be worn and subsequently replaced. A review of the customer's hemo case management within merge healthcare's internal database found that no other calls have been placed by the customer for this issue. Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence in the troubleshooting section by statements such as, "problem - an application (the hemodynamics application or an external application) is frozen. Resolution - press ctrl+alt+delete and click task manager. Find application in the applications list and click end task. It may take several seconds for the task to be stopped. Restart application to resume. " (b)(4). , communication or transmission issue (issue associated with the device sending or receiving signals or data. This includes transmission among internal components of the device and other external devices to which the device is intended to communicate. ) actual device evaluated. Results - wear problem (device problems due to the premature or expected erosion of its material by use, deterioration, or change). Conclusions - device difficult to operate.
 
Event Description
Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure. The system comprises the patient data module and the merge hemodynamics hemo monitor pc. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the patient data module. This data is then transmitted to the merge hemodynamics hemo monitor pc via the serial interface. All data can be shown and monitored on the merge hemodynamics hemo monitor pc. On (b)(6) 2018, a customer reported to merge healthcare that the pdm (patient data module) was buzzing and the waveform display (hemo monitor) froze. Information obtained from the customer revealed that this issue has occurred several times - some incidents occurred at the end of procedures, the patient data was not affected, and the procedures were completed successfully. During another incident the issue occurred prior to starting the procedure. The patient was moved to a known working lab and the procedure was completed successfully. However, during another incident the issue occurred during the procedure and subsequently the patient was moved to a known working lab after sedation and active monitoring had been initiated. It was reported that the procedure was completed successfully. Information also obtained from the customer found that the issue has been ongoing in this lab. Even though the site has multiple labs available for use, it was the customer's choice to continue to perform procedures in this lab. Exact dates were unknown to the customer, so the customer's call in date, (b)(6) 2018, has been reflected, date of event. With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient. However, the procedure was completed successfully once the patient was moved to a known working lab. (b)(4).
 
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Brand NameMERGE HEMODYNAMICS
Type of DevicePROGRAMMABLE DIAGNOSTIC COMPUTER
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge drive
hartland, WI 53029
2623670700
MDR Report Key7295010
MDR Text Key101026418
Report Number2183926-2018-00015
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 01/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.0.3 PATCH 1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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