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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 9.40.3
Device Problems High Readings (2459); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2016
Event Type  malfunction  
Manufacturer Narrative
The customer informed merge technical support that a similar problem occurred in another lab at their site and it was caused from a faulty link assembly on the pdm (patient data module). Tech support sent the customer the replacement hardware on (b)(6) 2016 and it was confirmed that the problem was corrected. The alleged faulty hardware was received by merge healthcare for evaluation on (b)(6) 2016. An evaluation of the unit showed that there were no problems with it. The hemo user manual, addresses the potential for such an occurrence by providing instructions on how to use the merge-supplied simulator to aid in troubleshooting. For this reason, (b)(4) (human factors issue) was used.
 
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) 2016, a customer reported to merge healthcare that they experienced high ecg output values when using the link assembly. Information obtained from the customer revealed that the problem resulted in ffr (fractional flow reserve) data not being obtained. The procedure was completed successfully without the data; however, the attending physician was not able to place a stent. The patient was placed on "medical management" through medication and scheduled to return in ninety (90) days to re-do a stress test. Depending on the results of the test, the patient may undergo a heart catheterization procedure again to place a stent. With merge hemo not presenting physiological data during treatment, there is a potential for incorrect treatment that results in harm to the patient. (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 Key5852531
MDR Text Key51387431
Report Number2183926-2016-00676
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 9.40.3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2015
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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