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

Model Number MERGE HEMODYNAMICS 10.1.2

Device Problem Power Problem (3010)

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

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

This issue is being further investigated by merge healthcare.A supplemental report will be submitted once the investigation is complete.

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) 2019, a customer contact reported to merge healthcare that during a case, the lab froze, beeping was heard from the patient data module (pdm), and the hemo system booted users out.They had to reboot the computer several times.Subsequently, the patient had to be moved to another lab to complete the case.Initial troubleshooting revealed that the 12 volt was out on the hemo pc.In addition, the customer stated that the pci card was frayed.With merge hemo not capturing physiological data, there was a delay in treatment/diagnosis that could potentially cause harm to the patient.However, there was no allegation of harm or injury to a patient or user as a result of this issue.(b)(4).

Manufacturer Narrative

In order to quickly resolve this customer's issue onsite, replacement hardware was sent.The replaced hardware was installed and resolved the customer's issue.The customer returned some of the allegedly malfunctioning hardware to merge healthcare for further evaluation.The hardware was evaluated and the pc was found to have a bad hard drive.The drive was over 2 years old therefore, this was not an abnormal occurrence.The issue with the fuse that the customer alleged initially, could not be confirmed.Additionally, any issues with the uninterruptible power supply (ups) could not be replicated.Per the hemo v10.1 user manual: general equipment care: inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required.Patient data module in the following, the led mentioned is located nearest to the out plug.Note: not all systems have a pb2000 installed.Check proper function: hemo monitor display is scrolling with proper waveforms.Pdm leds blink once every 2 seconds.No +12vdc present.Hemo monitor display stops scrolling.Pb1000 led blinks twice every 2 seconds.Pb1000 alarm sounds a continuous low tone.Pb2000 led blinks twice and then once at 1 second intervals.Led behavior: 5v led 4.5 to 5.5v.If it drops below or if there's a blown fuse on the hemo monitor pc's pci card, the led goes out.12v led 10 to 13.2v.Same behavior as the 5v led.If low voltage is detected, the pdm goes to battery power and an audible alarm sounds.H6 - evaluation codes: methods code: 10 - testing of actual/suspected device.Results code: 115 - maintenance problem identified.Conclusions code: 4307 - cause traced to component failure.

• 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: 8793254
• MDR Text Key: 154150164
• Report Number: 2183926-2019-00025
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00842000100034
• UDI-Public: 00842000100034
• 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: 06/17/2019

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
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.1.2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1