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

Model Number MERGE HEMO V10.0.1

Device Problem Device Issue (2379)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 02/10/2016

Event Type  malfunction  

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 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.All data can be shown and monitored on the hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that the site was experiencing a "lead off/reset" error on the ekg monitor.Subsequently, a new harness was shipped to the customer.Additional information revealed that the problem occurred while a patient was on the table; however, the procedure did not need to be rescheduled.This event resulted in the loss of capturing accurate ekg data for the patient.The device failed to perform an essential function which may lead to delay in diagnosis and/or treatment of patients.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted on 16mar2016.Merge technical support shipped the customer a replacement 5 lead ecg harness for v2 pdm.The faulty harness was returned to merge healthcare on 24feb2016 and was scrapped upon receipt (reference rma #(b)(4)).Follow-up communication with the customer confirmed that the problem was corrected with the replacement hardware.Device labeling, hemo-6373, v10 user manual, addresses the potential for such an occurrence in the general maintenance section with statements such as, "inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required." in addition, in the faq section statements such as, "question: why is the ecg display noisy or have gaps or resets? answer: noise can come from many places when recording ecgs.- unused leadwires should not be allowed to dangle, rather, attach leadwires to some out-of-the-way neutral location on the patient, such as near the rl electrode.- as discussed above, a hanging lead wire can move and cause the baseline to wander.- a cable on top of a patient may be disturbed by drapes.- patient tremor (uncontrolled muscle movements) can cause noise in the baseline.- dry pads do not conduct the electrical signal well enough to show a stable ecg.- a fractured lead will also cause the ecg to be noisy and the baseline to wander.- during some surgical procedures, an electronic device may be used to cauterize small vessel bleeding.This device will emit electrical interference that causes excessive noise on the ecg tracing.There is an optional cable available to suppress this noise.However, once this cable is connected, the respiration software can no longer be used.Revised information contained in this supplemental report includes the following: h3 - indication that device was returned.H6 - evaluation codes: method: 10 actual device evaluated.Results: 544 wiring harness.Conclusions: 13 device difficult to operate.H10 - indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: MERGE HEMO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5505085
• MDR Text Key: 40530031
• Report Number: 2183926-2016-00476
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMO V10.0.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1