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

Model Number MERGE HEMODYNAMICS 10.0.4 PATCH 1

Device Problems Electrical /Electronic Property Problem (1198); Failure to Power Up (1476); Smoking (1585); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

The ups was returned to merge healthcare for further evaluation.The results showed that the batteries had failed and cracked.The batteries were replaced but the unit would not turn on.It was scrapped because the unit was 4 years old and out of vendor warranty.A replacement unit was sent to the customer and no further ups issues were reported.The potential impact to a patient has been reviewed and the risk level has been assessed as low.Per hemo-6373 merge hemo 10 user manual: certifications (page 11) the system is in compliance with the product safety requirements defined in: ul 60601-1:2003, medical electrical equipment part 1, general requirements for safety.Can/csa c22.2 no 601.1-m90, medical electrical equipment - part 1: general requirements for safety.The system is in compliance with the electromagnetic compatibility requirements defined in: en 60601-1-2:2001, medical electrical equipment - section 1.2 collateral standard: electromagnetic compatibility - requirements and tests.En 55011:1998, amendment a1: 1999 and amendment a2:2002 - group 1.The system is classified by the federal communication commission (fcc) as class b digital devices as defined in fcc part 15 subpart b.(page 12-13) specific safety precautions: the system should only be plugged into a hospital grade outlet.Do not plug other equipment into the outlets in the merge hemo cabinet.Do not connect the remote operators terminal (rot) power strip to the record station ups.Always replace fuses with the same type (voltage and amperage).All values, analyses, and recordings must be reviewed by a qualified physician, nurse, or technologist for accuracy prior to acceptance.Dangerous voltages are present in many system assemblies.The unit should be used only in rooms that comply with recommendations concerning electrical safety when used for medical purposes.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.Attention! when used in patient vicinity, the device must be located on the secondary side of the medical grade isolation transformer provided in order to reduce leakage current to an allowable limit in compliance with ul 60601-1 clause 19.4.Caution: electrostatic discharge (esd) may damage components on circuit boards.Wear a wrist-type grounding strap or similar esd-grounding device when handling circuit boards.Failure to protect component from esd may cause damage to the component.

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 july 26, 2018, the customer contact reported that the uninterrupted power source (ups) in lab 1 stopped working and started smoking.There was no patient on the table during this time and the ups was swapped out.The customer contact further reported that two employees sought medical attention as a result of the smoking ups.There was no adverse event reported, however, further follow up has been sent to the customer for additional information on the user/employee impact.If additional information is received, a supplemental report will be submitted.The health effects of smoke inhalation is dependent on how much has been breathed and for how long.Effects can range from mild headaches or eye irritation to very serious unconsciousness and death.However, there was no report of ill effects from the smoke.If parts of the hemo system become energized, there is a potential for direct harm to the patient and/or user including electrical shock or burns.(b)(4).

Manufacturer Narrative

Additional information received from the customer indicating that no employees were treated as a result of the smoking ups.Revised information contained in this supplemental report includes the following: (b)(4).

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 22aug2018 and follow up report 001 submitted 11apr2019.Merge healthcare conducted an internal investigation (hemo-13331) and the following information was revealed: as stated in the initial report, there was no patient involvement during the event and was confirmed by the customer.It was incorrectly reported in the initial report that the actual ups had been scrapped due to warranty expiration and age of the unit.Merge healthcare retained the actual unit in the event that further evaluation was required.The initial customer allegation stated that two (2) hospital employees required medical assessment due to smoke inhalation from the event but was later retracted by the customer on 24aug2018.The customer reported to merge healthcare that the employees did not need medical assistance.This new information was reported to the fda in follow up 001.Supplier corrective action report (scar) issued to tripp lite by merge healthcare.Testing was conducted by tripp lite, the failed ups and internal battery were most likely operating at the high end of the permitted temperature range for this unit (40c, or 104f).No corrective actions are planned by tripp lite since this model is no longer in production (eol december 2015).The manufacturer suggests ensuring installation of the unit in a well ventilated cabinet that allows free air circulation from the outside through the cabinet.Health hazard evaluation (hhe) performed by merge healthcare: potential hazards that could occur are energy hazard due to high temperature (heat), energy hazard due to smoke, chemical hazard due to exposure to corrosive chemicals, and functional loss or deterioration of function of the ups.There are design factors that mitigate these risks.As a preventative measure, the hemo maintenance guide was updated to include information concerning ups maintenance, cleaning/disinfecting, and battery replacement/disposal.No further actions by merge healthcare are anticipated at this time due to the non-serious impact to the user, the confirmation that there was no patient involvement, the manufacturer's conclusion that there was no serious risk to the user, and the preventive measures taken by merge healthcare.Revised information contained in this supplemental report includes the following: corrected: patient identifier - none (no patient involvement).Corrected: indication that initial reporter was a health professional.Date new information received by manufacturer (risk matrix release date) 5/13/2019.Indication that this is follow-up report 002.Indication that reportable event due to malfunction.Indication of correction, additional information, and device evaluation.(b)(4).Indication of additional manufacturer information and corrected data are contained in this follow-up report.

• 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: 7807977
• MDR Text Key: 118259697
• Report Number: 2183926-2018-00079
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00842000100010
• UDI-Public: 00842000100010
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.4 PATCH 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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