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


  • 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

Device Problems Failure to Transmit Record (1521); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
Event Type  malfunction  
Manufacturer Narrative
A purchase order (po) was sent to the customer and is currently pending the return of this documentation for shipment of a replacement coil cable kit. Therefore conclusion (#11) was selected as the investigation is not yet complete. The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury). The merge hemo user manual includes a guide on the communication between the pdm and the hemo monitor pc, equipment care guide, and tips on frequently asked questions. Per hemo-6373 merge hemo 10 user manual: (p. 54) communication: record station when a command is issued by touching or clicking an icon on the client pc, the hemo monitor pc responds. Physiologic monitoring is accomplished by these two computers joined via unique communication protocols. There are three icons on the bottom of the hemo monitor, left of the time display, that are displayed as visual indicators of system status. The patient name is displayed at the top of the screen and the day, date, and time are displayed at the bottom of the screen. (person) 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. (p. 363) pdm 1. Check the physical condition of the pdm and its cleanliness. 2. Ensure that the calibration is current (according to the round sticker on bottom). If needed, order a replacement. Factory calibration is done before the unit is shipped. If the site requires the calibration of the unit to be checked, a transducer should be connected to a channel and 100 mmhg applied to the transducer with a mercury manometer. Ensure that it is within the ±1% tolerance that is allowed by the manufacturer. If the unit is outside of this specification, it should be returned. General: inspect overall physical condition of the system components, peripherals, and interconnecting cables. Perform any corrective actions required. (p. 365) problem: an application (the hemodynamics application or an external application) is frozen. Resolution: press ctrl+alt+delete and click task manager. Find application in the applications list and click end task. It may take several seconds for the task to be stopped. Restart application to resume.
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. The customer contact reported that on (b)(6) 2018, the waveform monitor output (hemo monitor pc) was freezing for 3 seconds during electrocardiogram (ecg) monitoring in lab 5. During this time, the patient data module (pdm) started buzzing and the patient icon at bottom of screen started flashing (indicating an interruption in the communication between the hemo monitor pc to pdm). After a few seconds, the system recovered, the flashing person icon stopped alarming and waveform monitor unfroze. The biomedical engineer reset the pdm, as well as power cycled the hemo monitor pc. There was a three minute delay while the hemo monitor pc was rebooted and the case resumed immediately. There was no indication of patient harm as a result of this issue. However, with merge hemo being rebooted and not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient. (b)(4).
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge drive
hartland, WI 53029
MDR Report Key7680264
MDR Text Key113874572
Report Number2183926-2018-00058
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
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