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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problems Device Issue (2379); Device Operational Issue (2914)

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

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting with hemo support, the hemo pc and client pc were both rebooted and the pb-1000 5v and 12v lights were illuminated and the people icon was green.However, the spo2 was red and flashing.A spare finger probe worked as expected during troubleshooting with hemo support.The cable for the finger probe was on back order from masimo, therefore rma #(b)(4) was created.A replacement spo2 masimo pb-1000 lncs v2 cable was sent to the customer on (b)(6) 2018.The faulty unit was scrapped onsite by the customer.After the spo2 cable was replaced, the customer's allegation of spo2 not working was resolved.Per hemo-6373 merge hemo 10 user manual p.367: problem: the spo2 sensor intermittently displays erroneous or no values and/or waveform on the hemo monitor.Solution: ensure proper and secure placement of the spo2 sensor on the patient's extremity.It may also be necessary to check for proper connectivity of the spo2 harness interface cable at the pdm.

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) 2018, the customer contact reported to merge healthcare that during a case, the spo2 was not working.The user tried a known good cable from another room with no success.It was further reported that they transferred the patient post sedation to another room with merge monitoring.There was no adverse event reported, however; when a patient is transferred post sedation to another room because merge hemo was not working as intended, this could cause harm to the patient.Reference complaint-(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: 7278250
• MDR Text Key: 100523622
• Report Number: 2183926-2018-00012
• Device Sequence Number: 1
• Product Code: DQK
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.3 PATCH 1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1