MAUDE Adverse Event Report: DEFIBTECH L.L.C. DDU-1XX SERIES ADULT RESCUE PADS

Model Number	DDP-100
Health Effect - Clinical Code	Death (1802)
Date of Event	05/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the reporter understood the importance of returning the pads, and committed to returning them, multiple follow-ups resulted in the reporter stating that the pads are lost and may have been discarded.The pad lot number, expiration information, and age of the pads are unknown.This report is being filed since it is unknown how effectively a non-medical/professional use might be able to use pads with two right apical placement images.Should additional information become available, a follow-up mdr will be submitted.
Event or Problem Description
On may 9, 2016 it was reported by a professional user (emt) that when he went to use a set of adult defibrillation pads on a patient, he noticed that both pads had the same right apical image.He stated that he understood the correct location to place the pads and that he could have used them, but chose to use a spare set.He provided the electronic data from the aed used during the event and the analysis of the electronic data shows the patient was in an asystolic rhythm (a non-shockable rhythm) and that the aed performed as intended; no aed malfunctions were noted.It was reported that the patient was not resuscitated.No adverse event code was selected since the patient's ecg was non-shockable and therefore there is no suspected association between the patient's death and the use of the product.

• Brand Name: DDU-1XX SERIES ADULT RESCUE PADS
• Common Device Name: ADULT RESCUE PADS
• Manufacturer (Section D): DEFIBTECH L.L.C.; 741 boston post road; suite 201; guilford CT 06437
• MDR Report Key: 5707077
• Report Number: 3003521780-2016-00003
• Device Sequence Number: 190862
• Product Code: MKJ
• UDI-Device Identifier: 00815098020423
• UDI-Public: 00815098020423
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K013896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial
• Report Date (Section B): 05/09/2016

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: Emergency Medical Technician
• Device Model Number: DDP-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2016
• Initial Report FDA Received Date: 06/08/2016
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 109