MAUDE Adverse Event Report: MORTARA INSTRUMENT MCKESSON AM12 LAN AHA; ELECTROCARDIOGRAPH

Model Number MLBUR150C-C1X

Device Problem Insufficient Information (3190)

Patient Problem Electric Shock (2554)

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

The eli 150 device is indicated for use to acquire, analyze, display, and print electrocardiograms.To be used in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician.It is not intended as a sole means of diagnosis.The device is indicated for use on adult and pediatric populations.To prevent electric shock due to unequal ground potentials that may exist between points of a distributed network system or fault conditions in external network connected equipment, network cable shielding (where used) must be connected to protective earth ground appropriate to the area where the device is used.The customer will not be returning the device.It is noted that the customer utilizes a third party vendor (venture medical) for preventative maintenance and inspections for their medical devices.An inspection of this device by hillrom could not be performed as the device is not being returned, and is currently in the possession of the third party vendor for its inspection.The severity of shock from a given source will depend upon its path through the body.Low voltage (less than or equal to 380 volts) electric currents that pass through the body have well-defined physiologic effects.For a 1 second contact time, 1 ma is the threshold of perception ¿ causing a tingling sensation: or 5ma causing a maximum harmless current.It is likely the operator experienced discomfort or pain.Based on the details, that the medical intervention provided for the reported shock consisted of an evaluation resulting in one day of "rest" there is no indication that the event resulted in serious injury or permanent impairment of a body function or structure.However, due to the potential for serious injury to occur with reoccurrence, baxter/hillrom is cautiously reporting this event.

Event Description

It was reported that the caregiver received a shock when plugging in the eli 150 device.During a follow up call with the customer, the customer stated that there was no wound or burn from the reported shock, the caregiver was seen in an urgent care clinic for evaluation, and was given one day "hand rest" from work.The caregiver returned to work the following day with no residual effects from the event.This report was filed in our complaint handling system as (b)(4).

• Brand Name: MCKESSON AM12 LAN AHA
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14828142
• MDR Text Key: 303278196
• Report Number: 2183461-2022-00024
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2022

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 Model Number: MLBUR150C-C1X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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