LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

Report

Report Number: 3015876-2010-00586
Event Type: Injury
Date Received: May 7, 2010
Date of Event: April 9, 2010
Report Date: April 9, 2010
Manufacturer: PHYSIO-CONTROL, INC.
Product Code: MKJ
PMA / PMN Number: K991910
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B) (4): THE FACILITY BIOMED EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORTED PROBLEM. PHYSIO-CONTROL'S CLINICAL SPECIALIST EVENT RECORD ECG REVIEW OBSERVED WHAT APPEARED TO BE AN ECG ARTIFACT OF SOME KIND THAT WAS SENSED AS AN R-WAVE THAT RESULTED IN THE DISCHARGE OF THE DEFIBRILLATOR. THE ARTIFACT COULD RESULT FROM MOVEMENT OF THE PT OR ECG LEAD/ELECTRODE OR AN ABERRANTLY CONDUCTED BEAT. A SIMILAR ARTIFACT LIKELY REPRESENTING LEAD WIRE MOVEMENT WAS SEEN IN THE CONTINUOUS ECG ABOUT ONE MINUTE PRIOR TO THE SHOCK. PHYSIO IS ANTICIPATING THE DEVICE RETURN FO THE MFG FACILITY AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

Description of Event or Problem · 1

IT WAS REPORTED THAT DELIVERY OF A SYNCHRONIZED SHOCK TO A PT CONVERTED HIM/HER INTO A VENTRICULAR FIBRILLATION RHYTHM. THE PT WAS SUBSEQUENTLY SHOCKED UNSYNCHRONIZED AND SUCCESSFULLY CONVERTED TO A SINUS RHYTHM. THE PT WAS LATER DISCHARGED FROM THE HOSPITAL. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR PT PROVIDED. A CLINICAL REVIEW OF THE REPORTED INCIDENT DETERMINED THAT THE DEVICE USE CAUSED THE PT TO BE IN A LIFE-THREATENING CONDITION SINCE THE PT WAS IN A VIABLE STATE WITH ATRIAL FIBRILLATION AND DELIVERY OF THE SYNCHRONIZED SHOCK PRECIPITATED A VENTRICULAR FIBRILLATION (VF).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES		MKJ	PHYSIO-CONTROL, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Life Threatening\| R