• 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 HEMO 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 HEMO PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number MERGE HEMODYNAMICS 9.30
Device Problems Computer Software Problem (1112); No Display/Image (1183); Failure to Transmit Record (1521); Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2016
Event Type  malfunction  
Event Description
Merge hemo monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure. The system comprises the patient data module and the 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 hemo monitor pc via the serial interface. The transmitted patient data can be shown and monitored on the hemo monitor pc. On (b)(6) 2016, a customer reported to merge healthcare that the hemo monitor stopped functioning towards the end of a catheterization procedure. A loss in monitoring a patient's hemodynamic information during a procedure could lead to a delay in treatment; however, the customer did confirm that the patient's treatment was not delayed and the procedure was completed successfully by alternate means.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMERGE HEMO
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 Key5482745
MDR Text Key39755290
Report Number2183926-2016-00455
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 9.30
Device Catalogue Number9.30
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/27/2018
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
Removal/Correction Number2183926-02/15/2016-031-C

-
-