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

Model Number MERGE HEMODYNAMICS 9.40.3

Device Problems Malposition of Device (2616); Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

Information obtained from the customer revealed that v-leads were moved around to various locations on several patients to troubleshoot the problem; however, no specific instances were given and the results were the same.The customer's reported problem is currently under investigation by merge healthcare.When more information becomes available, a supplemental report will be submitted.

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) 2016, a customer reported to merge healthcare that the ekg output presented with a "mirror" effect.The customer indicated that patient care was affected because the user could not obtain a clear picture of the elevations and depressions of an anterior infarction as well as the qrs morphology was affected.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient.However, the customer stated that the procedure was completed successfully using a portable 12-lead ekg machine.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 25jul2016.Upon reviewing a test case output of the mirrored ekg results completed by the customer, merge healthcare followed up with the customer for more information concerning their reported problem.It was found that the mirrored images resulted from incorrect lead placement by the user.Instead of placing leads on opposite limbs, the leads were placed on the same limb which caused the mirrored effect.For this reason, conclusion code 19 (human factors issue) was used.The device labeling was enhanced in hemo v10 user manual (hemo-6373) making users aware of the recommended placement, "the left and right leg lead recommended location is to be attached to the appropriate leg below the waist.Do not attach them above or at the waist if possible because betadine may run to the electrode and lead.If resistive respiration is desired, the leg leads must be attached to the appropriate leg in order for the system to detect the change in resistance and count the respiration rate." revised information contained in this supplemental report includes the following: h6 - evaluation codes: methods code: 3304 in situ observation (observing the device in the exact same conditions and setting in which the device was used).Results code: 444 user interface.Conclusions code: 19 human factors issue.H10 - indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5818492
• MDR Text Key: 50301488
• Report Number: 2183926-2016-00657
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1