MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-04 for MERGE HEMODYNAMICS MERGE HEMODYNAMICS 10.0.3 PATCH 1 manufactured by Merge Healthcare.
[188865434]
Merge technical support worked with the customer to troubleshooting the issue. It was found that windows defender was actively running on the entire hemo system and caused a loss of communication between the hemo server and client pc. Once windows defender was deactivated, the workstation began to replicate with the hemo server, which allowed access and use of the interface, and corrected the customer's reported issue of grayed out chrono-log tabs. Merge hemo has labeling that includes product security recommendations. This documentation addresses the potential for this issue with statements such as, "merge healthcare recommends that the windows firewall service be disabled on the merge hemo server, cath lab clients, and ancillary workstations. The windows firewall has caused communication problems and poor performance between the merge hemo server and connected workstations. To accomplish this, the anti-virus software needs to be configured to scan only the potentially vulnerable files on the system, while skipping the medical images and patient data files. Our experience has shown that improper configuration of anti-virus software can have adverse effects including downtime and clinically unusable performance. " device labeling for hemo v10 includes equipment usage restrictions with statements such as, "do not load any software onto the hard drive as it may corrupt the system software. Only authorized service personnel should load software onto system components. " a review of the customer's hemo case management within merge healthcare's database confirmed that the customer has not reported this issue or similar issue to date. No further action by merge healthcare is anticipated at this time due to the issue being readily apparent to the user, the non-serious impact to a patient, and the customer's confirmation that the issue was resolved by deactivating the site's anti-virus software on the specified files. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188865435]
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) 2020 a customer reported to merge healthcare that the chrono-log tabs were grayed out in the hemo application user interface. The chronlog is the portion of the application where patient and procedure data are recorded and is used by the application to create the patient's study report. Clinical staff elected to move the patient to another onsite lab after sedation had been administered, rather than continue the procedure in the current lab with the chrono-log's tabs grayed out. With merge hemo not capturing physiological data during treatment, there is a potential for delay in treatment that could result in harm to the patient. However, the customer reported that the procedure was completed successfully and there was no adverse effect to the patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2020-00008 |
| MDR Report Key | 9788181 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2016-08-08 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN BELL |
| Manufacturer Street | 75 BINNEY STREET |
| Manufacturer City | CAMBRIDGE, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 3540189 |
| Manufacturer G1 | MERGE HEALTHCARE |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND, WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE HEMODYNAMICS |
| Generic Name | PROGRAMMABLE DIAGNOSTIC COMPUTER |
| Product Code | DQK |
| Date Received | 2020-03-04 |
| Model Number | MERGE HEMODYNAMICS 10.0.3 PATCH 1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERGE HEALTHCARE |
| Manufacturer Address | 900 WALNUT RIDGE DRIVE HARTLAND, WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |