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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 Problem Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
Troubleshooting activities included the customer replacing the blown fuse with a spare that is provided with the computer. After replacement, it was reported that the voltage light would not turn on. After checking all the connections again, a loose cable was found and reconnected. It was confirmed that the voltage light issue was resolved. The customer confirmed to merge technical support on 03aug2018 that the issue had been resolved. Merge technical support reminded the customer that the hemo system should be turned off prior to unplugging any parts of the workstation to prevent blown fuses. For this reason, conclusion code 61 (unintended use error) was used. The potential impact to a patient has been reviewed and the severity level has been assessed as medium (non-serious injury). Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence as noted in the led behavior section, "5 v led 4. 5 to 5. 5 v: if it drops below or if there's a blown fuse on the hemo monitor pc's pci card, the led goes out. " also found in the general equipment care section, it states, "inspect overall physical condition of the system components, peripherals, and interconnecting cables. Perform any corrective actions required. " no further actions are anticipated at this time due to the issue being readily apparent to the user, troubleshooting information provided in the user manual, and the potential non-serious injury 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 "???" displayed on the hemo monitor and the pdm (patient data module) was not working caused from a blown fuse on the 12 v. It was further reported that a patient was present and was under sedation causing a delay in treatment to be greater than fifteen (15) minutes while the fuse was changed out and the hemo system rebooted. With merge hemo not capturing physiological data, there is a potential for incorrect treatment that could cause harm to the patient. The procedure was completed successfully once the fuse was replaced and the hemo application 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
meg mucha
900 walnut ridge drive
hartland, WI 53029
2623670700
MDR Report Key7831482
MDR Text Key119339519
Report Number2183926-2018-00082
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 08/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2018
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? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
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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