HospitalInspections.org

Based on observation, interview, policy review, and manufacturer's instructions for use (IFU) review, the provider failed to ensure:
*Two of two Lifepak 15 defibrillators located in two of two emergency department (ED) trauma rooms (1 and 2) had been checked per the manufacturer's IFU.
*One Lucas (machine that provides chest compressions) device located in the ED trauma room 1 had been checked per the manufacturer's IFU.
Findings include:

1. Observation and interview on 12/9/24 at 1:24 p.m. in trauma room 1 and 2 with director of nursing (DON) A revealed:
*Two Lifepak 15 defibrillators and a Lucas device.
*She stated the Life Pak 15 defibrillators had been checked daily and signed off on the provider's day shift checklist.
-There were no instructions on the shift checklist on how to check the defibrillators.
*Staff should have performed the user test and printed off the pass/fail slip.
*She stated the Lucas device's battery was switched out monthly for charging as indicated on the provider's night shift checklist.
*No manufacturer's IFU were located on either the defibrillator or the Lucas device for staff to reference on how to check the devices.
*She was unaware of what the manufacturer's IFU required for routine checks for the defibrillators and the Lucas device.

Observation and interview on 12/9/24 at 2:15 p.m. in trauma room 1 with registered nurse (RN) B revealed she:
*Stated the Lifepak 15 defibrillators in the two trauma rooms had been checked daily.
*Performed the daily check as indicated on the provider's checklist.
-Pressed the analyze button and was unsure of what to press next.
-Selected user test and the machine printed out a slip indicating it had passed.
-Stated this was all they did for their daily checks.
*Was unsure of how to charge the defibrillator to deliver the appropriate joules (amount of energy delivered to a patient's heart from a shock).
-Stated, "I can't remember how to perform the shock test."
*Stated there were no operator instructions on how to perform these checks on the defibrillator.
*Stated they had not unplugged the defibrillator from the wall during those daily checks.
*Stated the Lucas device's battery was changed monthly per the provider's checklist and signed off.
*Was unaware of any weekly checks regarding the Lucas device.
*Stated, "We just make sure the battery is charged every day."

Interview on 12/9/24 at 2:51 p.m. with DON A confirmed staff had not been performing the recommended daily and weekly checks as instructed per the manufacturer's IFU for the Lifepak 15 defibrillators and Lucas device.

Review of the provider's 11/23 Code Cart Check policy revealed:
"Purpose:
-To ensure the availability of medication and supplies in emergency situations and ensure professional staff maintain familiarity with the drugs that are administered and the equipment/supplies that are used in an emergency situation.
*Procedure:
-The processional licensed staff will be involved with checking and stocking of the crash carts to make sure medications and supplies are stocked and equipment is working properly after each use.
-The Lifepak 15 is checked every 24 hours and documented on the checklist."

Review of the 10/11 Lifepak 15 Monitor/Defibrillator manufacturer's operating instructions for
use (IFU) checklist revealed:
*"Daily inspection and testing of the Lifepak 15 monitor/defibrillator is recommended.
*1. Inspect physical condition for:
-Foreign substances
-Damage or cracks
*2. Inspect power source for:
-Broken, loose, or work battery pins
-Damaged or leaking battery
-Spare battery available
-Damage to power adapter and cables
*3. Inspect ECG cable and cable port for:
-Cracking, damage, broken, or bent parts or pins
*4. Check ECG electrodes and therapy electrodes for:
-Use By date
-Spare electrodes available
-Damaged, opened package
*5. With batteries installed, disconnect from power adapter, press ON and observe for:
-Momentary illumination of self-test messages and LED's, and speaker beep
-Two fully charged batteries
*6. With batteries installed, reconnect power adapter to device and check for:
-Power adapter LED strip is illuminated
-Auxiliary power LED on device is illuminated
-Battery charging LED on device is illuminated or flashing
7. Perform QUIK-COMBO therapy cable check in Manual mode:
-a. Disconnect and examine cable for cracking, damage, broken, or bent parts or pins.
-b. Connect therapy cable to defibrillator and the Test Load.
-c. Select 200 JOULES and press CHARGE.
-d. Press shock button
-e. Confirm ENERGY DELIVERED message appears.
-f. Remove Test Load from cable and verify either PADDLES LEADS OFF or CONNECT ELECTRODES appears."

Review of the 2009 Manufacturer's IFU for the Lucas 2 Chest Compression System revealed:
"Weekly, and after each use of the LUCAS Check Compression System, do the following:
-1. Make sure that the device is clean.
-2. Make sure that a new Suction Cup is installed.
-3. Make sure that the Patient Straps are attached.
-4. Make sure that the two support leg straps of the Stabilization Strap are attached around the support legs.
-5. Pull the release rings upward to make sure that the claw locks are open.
-6. Make sure that the Battery is fully charged.
-7. Push ON/OFF to make LUCAS do a self-test. Make sure the ADJUST LED illuminated with no alarm or warning LED.
8. Push ON/OFF to power down LUCAS again."