FDA Adverse Event Injury Summary report: N

LIFELINE AED

MDR report key: 1344993 · Received March 16, 2009

Report

Report Number: 3003521780-2009-00005
Event Type: Injury
Date Received: March 16, 2009
Date of Event: January 2, 2009
Report Date: February 12, 2009
Manufacturer: DEFIBTECH, LLC
Product Code: MKJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVAL: THE ELECTRONIC HISTORY RECORD FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THE ACTUAL DEVICE WAS NOT RETURNED. RESULTS: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS. THE INTERNAL DEVICE RECORD WAS REVIEWED. THE REVIEW CORROBORATES THE INFO THAT WAS PROVIDED BY THE FIRST RESPONDER. WITHOUT THE DEVICE, THE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONAL ATTEMPTS ARE BEING MADE TO HAVE THE DEVICE RETURNED AND THE INVESTIGATION REMAINS OPEN.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, WHEN THE ON BUTTON WAS PRESSED, THE DEVICE WOULD POWER ON AND THEN IMMEDIATELY POWER OFF. IT WAS REPORTED THAT THIS OCCURRED 3 OR 4 TIMES BEFORE THE DEVICE POWERED ON AND REMAINED ON. THE DEVICE THEN ANALYZED AND A SHOCK WAS ADMINISTERED. THE FIRST RESPONDER REPORTED FEELING THE SHOCK WHEN IT WAS DELIVERED AND THAT THE STATUS INDICATOR ON THE DEVICE TURNED RED. THE FIRST RESPONDER ALSO REPORTED THAT DURING THE PAUSE FOR CPR, THE DEVICE POWERED OFF. THE FIRST RESPONDER POWERED THE DEVICE, IT REMAINED ON AND ANALYSIS CONTINUED. NO FURTHER SHOCKS WERE REQUIRED AND THE PT WAS TRANSFERRED TO ANOTHER DEFIBRILLATOR. IT WAS REPORTED THAT THE PT SURVIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIFELINE AED	SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR	MKJ	DEFIBTECH, LLC	DDU-100E-NL	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR		Life Threatening