BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

MDR report key: 1300039 · Received January 31, 2009

Report

Report Number: 3015876-2009-00088
Event Type: Death
Date Received: January 31, 2009
Date of Event: December 23, 2008
Report Date: December 30, 2008
Manufacturer: PHYSIO-CONTROL, INC.
Product Code: MKJ
PMA / PMN Number: K983393
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE, AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THEY RESPONDED TO A PATIENT CALL. THEY WERE DISPATCHED AT 21:56 AND ARRIVED AT 22:01. THE CUSTOMER STATED THAT THE PATIENT WAS MALE, BUT WOULD NOT PROVIDE ANY OTHER PATIENT DEMOGRAPHICS. ALSO, THE REPORTER WAS UNSURE IF THE PATIENT ARREST HAD BEEN WITNESSED. THE LP500 DEVICE WAS ATTACHED TO THE PATIENT WITH PHYSIO-CONTROL PADS WHEN THE DEVICE CONTINUED TO PROMPT "CONNECT ELECTRODES". NO EXCESSIVE HAIR OR DIAPHORESIS WAS NOTED. ANOTHER PRIVATE AMBULANCE COMPANY RESPONDED TO THE CALL AS WELL, AND PATIENT CARE WAS TRANSFERRED TO THEIR DEVICE, USING THE SAME PHYSIO-CONTROL PADS. THE CREW WAS THEN ABLE TO PICK-UP AND DEFIBRILLATE THE PATIENT. THE TRANSFER TIME BETWEEN DEVICE ONE AND DEVICE TWO WAS APPROXIMATELY THREE MINUTES. THE PATIENT WAS NOT RESUSCITATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR		MKJ	PHYSIO-CONTROL, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Death