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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

Merge technical support shipped replacement hardware, a tripp lite1000va ups (rma #13581), to the customer on 15dec2017.The customer has yet to return the unit to merge healthcare for evaluation.A supplemental report will be submitted once the evaluation results are completed.

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) 2017, the customer contact reported to merge healthcare that during preparation of a case, the uninterrupted power source (ups) in lab 3 was fried.The staff reported smoke coming from the ups, however, when the customer contact arrived on scene, there was an odor coming from the ups but no smoke was seen.When a component emits a "burn" smell, hydrogen sulfide has been emitted.The health effects of hydrogen sulfide depend on how much hs2 has been breathed and for how long.Many effects are seen even at low concentrations.Effects range from mild headaches or eye irritation to very serious unconsciousness and death.However, there was no report of ill effects from the hydrogen sulfide emission.With smoke &/or a smell/gas being emitted from an electrical component, there is a potential for little to no impact, to those breathing in the smoke/smell, to a potential for harm.The customer has not reported any ill effects as a result of exposure to the smoke & or the resulting smell.(b)(4).

Manufacturer Narrative

The results of the hardware evaluation for the ups determined a hardware failure.The returned ups would not turn on.The batteries were bad and were replaced.Then the unit passed all tests.No evidence smoke was found during testing.

• 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: 7184487
• MDR Text Key: 97740499
• Report Number: 2183926-2018-00004
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

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 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: No
• 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