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

Model Number DDU-100E

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Death (1802); Electric Shock (2554)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

Examination of the event file reveals a lengthy rescue event nearly 45 minutes in duration.The patient's initial ecg rhythm appears to be ventricular fibrillation (vf), a shockable rhythm.In the 1st and 2nd analysis periods, the aed properly recognized vf, advised shock and prepared to deliver a shock.During charging, the ecg signal became saturated (the reason for this mdr) which the aed recognized, recorded error 550, indicating that the saturated ecg signal had occurred, and the shock was delivered to the patient.In the 3rd and 4th analysis periods, the patient's ecg rhythm continues to be vf which the aed properly recognized and initiated charging.During charging the aed detected patient motion and aborted the shock preparation.In the 5th and 6th analysis periods, the patient's ecg rhythm remains vf which the aed appropriately recognized, advised, and prepared for shock.During charging, the ecg signal became saturated which the aed recognized, recorded error 550, indicating that the saturated ecg signal had occurred, and the shock was delivered to the patient.In the 7th, 8th and 9th analysis periods, the patient's ecg rhythm continues to be vf which the aed properly recognized and initiated charging.During charging, the aed detected patient motion and aborted shock preparation.In the 10th thru the 15th analysis periods, the patient's ecg rhythm was vf which the aed appropriately recognized as shockable, advised shock, and delivered a shock to the patient which appears to have momentarily converted the patient's rhythm but they re-fibrillation soon during the cpr period which follows.In the 16th analysis period, the patient's ecg rhythm continues to be vf which the aed appropriately recognized as shockable, advised shock, and prepared for shock delivery.The 11th shock was delivered and appears to have converted the patient's rhythm to a sustained non-shockable rhythm.In the 17th thru 22nd analysis periods, the patient's ecg rhythm appears to be a wide-complex junctional rhythm, a non-shockable rhythm, which the aed appropriately recognized as non-shockable and did not advise a shock.The aed was powered off following the 22nd analysis period, and by design, the aed reported the error 550 observed during the event.No additional event data was recorded.The aed associated with this event was requested so that it may be evaluated and tested.However, to date, the aed has not been received, and the cause for the event is still underway.

Event Description

An international distributor reported seeing an error code recorded on an aed's electronic event file when reviewing a rescue attempt on a (b)(6) year-old male patient who was shocked eleven times.The international distributor reported that the patient was not resuscitated.

• Brand Name: LIFELINE AED
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• Manufacturer (Section G): DEFIBTECH, L.L.C.; 741 boston post road; suite 201; guilford 06437
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford 06437 ; 2034536654
• MDR Report Key: 8908156
• MDR Text Key: 155199232
• Report Number: 3003521780-2019-00017
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DDU-100E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 47 YR