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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE HEMO PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number MERGE HEMO
Device Problems Erratic or Intermittent Display (1182); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2016
Event Type  malfunction  
Manufacturer Narrative
As of 02/26/2016, merge healthcare support is continuing to work with the customer to troubleshoot and resolve this issue of the intermittent waveform delays on the hemo monitor.
 
Event Description
Merge hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure. A customer contacted merge healthcare support alleging that the hemo monitor screen would freeze unexpectedly for a few seconds on and off during a catherization procedure. With merge hemo not displaying physiologic data consistently during a cardiac catherization procedure, there is a potential for a delay in care that could result in harm to the patient. The customer did confirm that the procedure was completed successfully and there was no harm to the patient.
 
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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 Key5465401
MDR Text Key39207489
Report Number2183926-2016-00458
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,Followup
Report Date 02/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMO
Device Catalogue Number9.40.3
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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