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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 10.1
Device Problems Communication or Transmission Problem (2896); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
During troubleshooting efforts with the customer, merge healthcare technical support instructed the user how to reset the pdm (patient data module) as well as the hemo monitor and client pc in the proper boot up sequence. The customer confirmed that the issue was resolved. The potential impact to the patient has been reviewed and the risk level has been assessed as medium (non-serious injury). Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence in the troubleshooting section by statements such as, "problem - ecg error messages, resolution - several possible messages may appear on the hemo monitor if the system is unable to achieve reliable vitals readings. For example, if a lead is not properly attached to the patient or to the pdm, rather than offer a weak or inaccurate reading, the hemo monitor will indicate the affected lead with a lead off or not available message in white text. Check the lead's connection to the pdm and to the patient. Check for kinks or damage". No further actions are anticipated at this time due to the issue being readily apparent to the user and the non-serious impact to a patient. (b)(4).
 
Event Description
Merge hemodynamics displays, 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) started alarming and no patient vitals were displayed in the middle of a procedure. Subsequently, the patient was moved to another lab. With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient. However, it was reported that the procedure was completed successfully once the patient was moved to a known working lab. Reference complaint (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 Key7594518
MDR Text Key110878872
Report Number2183926-2018-00050
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 05/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2017
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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