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

Model Number	MERGE HEMODYNAMICS 10.0.4 PATCH 1
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Merge technical support shipped the customer a replacement v2 4p masimo nibp 2.X pdm (patient data module) on 22jun2018 (rma # (b)(4)).The faulty unit was sent to the manufacturer for evaluation and received by merge healthcare on 10jul2018.The manufacturer's evaluation results showed that the customer's reported problem, pressure ports not working, was confirmed.The manufacturer replaced the ibp circuit board and then re-certified the unit.Upon receipt, merge healthcare tested the unit according to (b)(4) and it passed.The customer confirmed to tech support on (b)(6) 2018 that the replacement pdm corrected the issue.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).No further actions are anticipated at this time due to the non-serious impact to a patient and the customer's confirmation that replacement hardware corrected their reported issue.(b)(4).Method: actual device evaluated.Results: circuit board.Conclusions: caused traced to component failure.
Event or Problem 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, a customer reported to merge healthcare that a freezing issue occurred during two (2) back-to-back procedures.During the first occurrence, the freezing issue prevented a patient's blood pressure values from being displayed.Both the hemo monitor and client pc were rebooted after the patient had been sedated and active monitoring had started.During the second occurrence, the medical staff realized it was an nibp (non-invasive blood pressure) issue and subsequently used a manual blood pressure cuff to obtain the patient's blood pressure values.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the customer emphasized that there was no negative effect to either patient due to the reported issue.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Common Device Name: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 7696203
• Report Number: 2183926-2018-00059
• Device Sequence Number: 11080004
• Product Code: DQK
• UDI-Device Identifier: 00842000100010
• UDI-Public: 00842000100010
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K082421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.4 PATCH 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1