• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number MERGE HEMODYNAMICS 9.30
Device Problem Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2018
Event Type  malfunction  
Manufacturer Narrative
First occurrence: at the customer's request, a spare trunk cable was shipped to the site for additional troubleshooting (rma (b)(4)) along with the assistance of a mera (medical equipment repair associates) technician so that a faulty trunk cable could be ruled out. Upon connection of the spare trunk cable, it was confirmed that there was still no power to the unit. It was determined that a fuse had blown on the pdm (patient data module) and was subsequently replaced. The customer confirmed that the issue was resolved. The potential impact to a 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 as noted in the following sections: communication - record station: person icon - "this icon appears to indicate communication between the hemo monitor pc and the patient data module (pdm). If there is a problem with any of the functions represented by the above three images, the icon color will switch to red. " 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. " general equipment care section: "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 the person icon located within the hemo application was flashing indicating a disconnection between the hemo monitor and pdm (patient data module). This occurred during a procedure and resulted in the use of portable blood pressure monitoring and third party equipment to capture the patient's invasive pressures. Additional information obtained from the customer revealed that the problem occurred twice on different days, (b)(6) 2018. With merge hemo not capturing physiological data, there is a potential for incorrect treatment that could cause harm to the patient. However, the customer confirmed that both procedures were completed successfully by using third party equipment. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7766076
MDR Text Key117019697
Report Number2183926-2018-00070
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 07/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 9.30
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-