FDA Adverse Event Injury Summary report: N

MEDTRONIC PHYSIO CONTROL

MDR report key: 2023494 · Received March 14, 2011

Report

Report Number
MW5019819
Event Type
Injury
Date Received
March 14, 2011
Date of Event
March 14, 2011
Report Date
March 14, 2011
Manufacturer
PHYSIO
Product Code
MKJ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PT PRESENTED IN CARDIAC ARREST. ALS PROVIDERS ON SCENE FOUND PT IN V-FIB, APPLIED QUIC COMBO PADS TO PT AND ATTEMPTED TO DEFIBRILLATE PT AT 200J, PER PROTOCOL. LP12 MADE ASCENDING TONE AS THOUGH IT WERE CHARGING TO 200J, BUT WHEN THE PROVIDER PRESSED THE "SHOCK" BUTTON, THE UNIT FAILED TO DELIVER A SHOCK. PT STILL IN V-FIB, SO A 2ND ATTEMPT TO SHOCK AT 200J WAS CONDUCTED WITH THE SAME RESULT: CHARGED TO 200J, BUT DID NOT DELIVER SHOCK. PT WAS STILL IN V-FIB, SO THIS TIME, THE PROVIDER TRIED CHARGING TO 300J. THE UNIT CHARGED, AND DELIVERED A SHOCK. PT CONTINUED IN V-FIB, SO THE PROVIDER CHARGED TO 360J, AND SUCCESSFULLY DELIVERED A SHOCK. PT THEN IN ASYSTOLE, SO NO FURTHER DEFIB WAS INDICATED. LATER, A REVIEW OF THE CODE SUMMARY REVEALED EXACTLY WHAT THE PROVIDER REPORTED: 2 FAILED ATTEMPTS TO SHOCK AT 200J; FOLLOWED BY A SUCCESSFUL DELIVERY OF ENERGY AT 300J, THEN AT 360J. ONE ALS AND ONE BLS PROVIDER ALSO AT THE SCENE TO WITNESS EVENT. THEY CONCURRED WITH THE PRIMARY PROVIDER'S ACCOUNT OF THE CIRCUMSTANCES. THEY SAW AND HEARD THE UNIT CHARGE TO 200J, THEN WATCHED AS THE PROVIDER TRIED TO DELIVER THE SHOCK BY PRESSING THE "SHOCK" BUTTON WITHOUT SUCCESS, X 2. DATES OF USE: APPROXIMATELY 9 YEARS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC PHYSIO CONTROL LP12 CARDIAC MONITOR/DEFIBRILLATOR MKJ PHYSIO VLP12-02-002986

Patients

Seq Age Sex Outcome Treatment
1 83 YR