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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 10.0.1
Device Problems Application Program Version or Upgrade Problem (2881); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2017
Event Type  malfunction  
Manufacturer Narrative
Merge technical support remotely accessed the customer's system and found that the nic (network interface card) was connected at 100half that caused a duplex mismatching. The customer was notified of the finding and the site changed their network so the hemo monitor and client pc matched. However, on (b)(6) 2017, the customer called in again with the same problem. During remote access by merge technical support, it was discovered that windows defender was running on the client pc. Tech support disabled the software and rebooted the unit. The nic on the client pc was set to match the hemo monitor nic at 100full. During this time it was also found that the replacement hemo monitor previously shipped to the customer on (b)(6) 2016 was preloaded with hemo software that had a different version than what the customer used. Since the software versions conflicted, it has been determined to be the root cause of the customer's reported problem for both occurrences. Once the version was downgraded to hemo v10. 0. 1 and windows defender disabled, the problem was corrected. The customer confirmed on 19jan2017 that the hemo system has been functioning correctly since (b)(6) 2017. Since the problem and resolution are the same but occurred on different dates, two (2) separate mdrs will be submitted. Reference mdr #2183926-2017-00021 for the first occurrence and event specific details.
 
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) 2017, a customer reported to merge healthcare that the hemo monitor froze in the middle of a procedure after active monitoring and sedation had been initiated. Subsequently, the hemo monitor was rebooted that resulted in a loss of patient monitoring. The delay was ~10-15 minutes while the hemo system rebooted. With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient. However, the customer reported that the procedure was completed successfully once the hemo monitor was rebooted. (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
michael diedrick
900 walnut ridge drive
hartland, WI 53029
2629123570
MDR Report Key6313303
MDR Text Key67135939
Report Number2183926-2017-00022
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 01/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.0.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2015
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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