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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number MERGE HEMODYNAMICS 10.0.1
Device Problems Battery Problem (2885); Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 04/10/2017
Event Type  malfunction  
Manufacturer Narrative
Merge technical support shipped replacement hardware, a ups tripp lite 1000va (rma #(b)(4)), to the customer on 10apr2017. The faulty unit was returned to merge healthcare by the customer and was received on 18apr2017 for evaluation. The results showed that the batteries were cracked and caused the odor to emanate. The batteries were subsequently replaced and the unit passed all testing. A review of the customer's case management in merge healthcare's database on 06may2017 confirmed that the customer has not called in again regarding a ups issue to-date.
 
Event Description
Merge hemodynamics monitors, 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) 2017, a customer reported to merge healthcare that the ups (uninterrupted power supply) emitted a sulfur odor. There was no patient involvement nor any report of medical staff harm due to the odor. With a smell/gas being emitted from a ups, there is a potential for a reaction to those breathing in the smell which could lead to a possibility for harm. The customer has not reported any ill effects as a result of exposure to the ups smell. (b)(4).
 
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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
michael diedrick
900 walnut ridge drive
hartland, WI 53029
2629123570
MDR Report Key6553313
MDR Text Key74706824
Report Number2183926-2017-00107
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
Type of Report Initial
Report Date 04/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.0.1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2015
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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