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

Model Number MERGE HEMODYNAMICS 10.0.1

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare remotely accessed the customer's logs and found that the problem was related to the site using a video switcher to send different video signals to the hemo monitor when it is not in use.The video switching device was site supplied and not a merge accessory.Device labeling , hemo 10 user guide, addresses the potential for such an occurrence with statements such as: "the equipment described in this manual may not be used in conjunction with other equipment, unless other equipment has been designated acceptable by merge healthcare;" "merge healthcare will not be responsible for support of customer supplied equipment;" and attention! the use of accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold by merge healthcare as replacement parts for internal components, may result in increased emissions or decreased immunity of the system." based upon the available information, there is no indication that the reported problem was caused by a device defect and/or malfunction but rather by the device being incorrectly prepared for use.

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) 2016, a customer reported to merge healthcare that the hemo system froze during an active case.Information obtained from the customer revealed that the respiration and pressure waveforms were co-joined and presented as one waveform, and the blood pressure presented with a deformation that looked like a barcode on top of it.It was further stated that the procedure was delayed twelve (12) minutes due to stopping the case to reboot the hemo system.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that results in harm to the patient.However, the customer reported that the case was completed successfully once the system was rebooted.Reference complaint number (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: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5781423
• MDR Text Key: 49131065
• Report Number: 2183926-2016-00632
• 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: Other
• Type of Report: Initial
• Report Date: 06/09/2016

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 10.0.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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