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

Model Number MERGE HEMO

Device Problems No Display/Image (1183); Failure to Transmit Record (1521); Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device is a (b)(4) t3500 hemo 9.20.3 and was shipped from merge healthcare's (b)(4) site to the customer on february 4, 2016.Evaluation in progress.

Event Description

Merge hemo monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the 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 hemo monitor pc via the serial interface.The transmitted patient data can be shown and monitored on the hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that, prior to a cardiac catheterization case, the hemo monitor became stuck, the screen turned blue, and the system could not be restored.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient.However, the event occured before patient treatment was underway, so there was no patient harm.

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 04mar2016.Merge technical support shipped the customer a replacement hemo monitor pc on 04feb2016.The faulty unit was returned to merge healthcare on 22feb2016 for evaluation.The results showed that the unit's hard drive failed diagnostic testing.The customer confirmed that the issue was resolved upon installation of the replacement unit.(reference rma #(b)(4).) during documentation review activities conducted by merge healthcare, it was found that the initial report was filed in error.As stated in b5 of the initial report, "the event occurred before patient treatment was underway, so there was no patient harm." additionally, patient problem code: (b)(4) (no patient involvement) was used in the initial report.Revised information contained in this supplemental report includes the following: h6 - evaluation codes: methods code: 10 actual device evaluated.Results code: 3213 interoperability problem (a problem with the mechanical, electrical, or communication interface between two or more separate devices or components).Conclusions code: 13 device difficult to operate.H10 - indication of additional manufacturer information and corrected data are contained in this follow-up report.

• Brand Name: MERGE HEMO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5481933
• MDR Text Key: 39749533
• Report Number: 2183926-2016-00464
• Device Sequence Number: 1
• Product Code: DQK
• 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: 02/04/2016

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 HEMO
• Device Catalogue Number: 9.20.3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1