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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE HEMODYNAMICS COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number MERGE HEMO V. 9.30
Device Problems Computer Software Problem (1112); Application Program Problem (2880); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2013
Event Type  malfunction  
Manufacturer Narrative
Upon retrospective review, this issue was determined to be reportable as an mdr.
 
Event Description
The merge hemodynamic recording system is used to monitor o2 saturation while performing cardiac catheterization procedures. It was reported that the spo2 value could freeze on the hemo monitor. If pulse rate is being measured using the spo2 values, then the pulse rate also freezes, which causes the hemo monitor to display stale data. A single lab site reported the oxygen saturation levels (spo2) failed on version 9. 30 of merge hemo on (b)(6) 2013.
 
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Brand NameMERGE HEMODYNAMICS
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
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
michael diedrick
900 walnut ridge dr.
hartland, WI 53029
2629123570
MDR Report Key5339677
MDR Text Key34885585
Report Number2183926-2015-00107
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
Remedial Action Recall
Type of Report Initial
Report Date 01/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMO V. 9.30
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 Received01/09/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Number2183926-9/24/2014-002-C

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