MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE ECG; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	DDU-2450
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of files from aed sn (b)(4) reveals an event on (b)(6) 2021 lasting 674 seconds and consisting of no analysis periods and no shocks delivered.The aed was powered on, and while the aed was a ddu-2450, which has the option for ecg mode which will show the patient's ecg, the default setting for this aed was aed mode, which displays the instructional videos of operation of the aed to the user.We believe that this caused the confusion reported by the customer.During the video prompts, the user unplugged and re-inserted the pads but did not apply the pads to the patient within 90 seconds of the aed turning on.By design, if the aed does not detect that the pads have been applied the aed switches from the apply pads prompts to pause for 2 minutes of cpr and provides cpr guidance such as a cpr metronome and a cpr countdown.During the cpr period there is a second instance of the pads being unplugged, and then shortly after, the pads are re-inserted into the aed.After the 2 minutes of cpr had completed, the aed switched again to the apply pads prompt sequence and during that time (60 seconds) the user still had not applied the pads.The aed again switched from the apply pads prompts to pause for 2 minutes of cpr.Thirty seconds after the cpr period began, the aed detected a valid patient impedance, indicating that the user had applied the pads.The aed, by design, continued the cpr sequence to complete the 2-minute sequence.Four seconds before the cpr period ended, the user unplugged the pads from the aed again.Had the user left the pads plugged in the aed could have analyzed the rhythm and made a shock decision.The pads were not plugged back into the aed for the rest of the rescue, and the aed performed another 60 seconds of apply pads prompts followed by a cpr period.During the cpr period, shortly before the next apply pads sequence, the aed was shut down by the user.Evaluation of the history file on and around the date of the event shows no service codes or warnings, apart from the no pad warning that was present upon shutdown.This warning was cleared later in the day when pads were attached to the unit.The aed performed as designed, no malfunctions are evident.
Event or Problem Description
A customer reported that they received an e-mail from a rescuer that the defibrillator did not work on a passenger and that the aed counted down but would not provide vitals.No additional information was available.

• Brand Name: LIFELINE ECG
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• MDR Report Key: 12322348
• Report Number: 3003521780-2021-00017
• Device Sequence Number: 17277230
• Product Code: MKJ
• UDI-Device Identifier: 10815098020284
• UDI-Public: 10815098020284
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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
• Operator of Device: No Information
• Device Model Number: DDU-2450
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1