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

Model Number MERGE HEMODYNAMICS 10.0.4 PATCH 1

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the case's full disclosure from hemo support found that the heat rate detection was set on lead 2.However the signal received on lead 2 would decrease then return throughout the case.During the times of decreased signal, the wave forms displayed on lead 2 would also decrease in size.The 3 and 5 leads were also displaying low amplitude from the patient.It was also noted that on lead 3, the lead polarity had also been reversed.Troubleshooting from the customer with a simulator while offline could not duplicate the issue.In addition, no further recurrences were noted.Additional information was received from merge hemo technical support that because the customer set the system to use lead 2 as the lead for heart rate detection, if a poor quality signal is received on lead 2, the system may have problems identifying r-waves, and can not properly calculate a heart rate.This could be due to poor lead placement, poor preparation by the staff before applying the electrodes, or just a poor signal from the patient.Hemo support recommends taking a 12 lead to see the raw data coming from the patient when they start a case.That way, if they have poor signals at that point they could re-position the electrodes for a better signal.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Per hemo-6373 merge hemo 10 user manual: page 222: lead selection select the lead to be displayed from the associated drop-down list.Note: place the best signal on tracing 1 to prevent false or inaccurate analysis.Note: if a poor signal is recorded on tracing 1, the system will have difficulty detecting the r-wave and thus have difficulty detecting the heart rate.Page 227: lead defines the ecg lead used to determine the heart rate.The auto setting is designed to provide a combination of multiple leads in order to attempt to adapt to changes in the ecg.Care must be taken when using this selection as it is important to review all leads prior to using this option and ensure that the quality of the leads will allow for adequate averaging.Often selecting individual leads provide a more stable heart rate on the hemo monitor.With this setting, the heart rate is triggered on lead ii.If however, the heart rate is not detected correctly, then it is possible to select a different lead on which the heart rate is then triggered.The selections available will depend on the patient cable used.3-lead cable ii (auto) 5-lead cable ii (auto), iii, v1 10-lead cable ii (auto), iii, v1, v2, v3, v4, v5, v6.If auto is selected, the pdm will try to use lead ii, iii, and v1 for the qrs detection.If one is missing it will exchange it with the other, so if ii is missing it will take iii two times.Page 383: general ecg question where should leads be placed? answer ideal lead placement is critical to achieve strong, accurate tracing.Do not allow unused leadwires to dangle, but rather attach to some out-of-the-way neutral location on the patient, such as near the rl electrode.For the cardiac cath lab, the best placement of the limb leads is below the clavicle on the soft tissue.This placement allows recording of both limb leads without actually placing leads on the arms (patients are often instructed to raise their arms during angiograms, so arm placement is not ideal).Leads placed on shoulders may pick up noise.Note: if attaching to the tissue below the clavicle, muscle tremors may occur in the arms when raised.The left and right leg lead recommended locations are 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.

Event Description

Merge hemodynamics displays, 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) 2018, the customer contact reported that the electrocardiogram (ecg) sweep speed tracings changed unexpectedly.It was reported that in the middle of a case without any initiated change from user, the heart rate went from 70 beats per minute (bpm) to 40 bpm, however the counting stayed the same.Subsequently, the patient was treated with an intervention when it was not needed.It was noted that lead 2 was off, therefore, they changed the sweep speed then changed it back and the ecg tracing and heart rate went back to normal.Additional information received from the customer contact that there was no adverse event to the patient as a result of the medication given.The healthcare professionals were able to monitor the patient and take counter measures as needed.No further information was provided regarding the event.If additional information is received, a supplemental report will be submitted.With merge hemo not capturing or capturing incorrect physiological data, the patient was incorrectly treated, which could have caused harm to the patient.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE 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 Key: 7725310
• MDR Text Key: 115544785
• Report Number: 2183926-2018-00063
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00842000100010
• UDI-Public: 00842000100010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.4 PATCH 1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1