FDA Adverse Event Death Summary report: N

STOCKERT RF GENERATOR

MDR report key: 1515511 · Received October 23, 2009

Report

Report Number: 9612355-2009-00038
Event Type: Death
Date Received: October 23, 2009
Date of Event: September 25, 2009
Report Date: September 25, 2009
Manufacturer: STOCKERT GMBH
Product Code: DRF
PMA / PMN Number: P990071
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE GENERATOR SETTINGS WERE AT TEMPERATURE CONTROL MODE 70 WATTS 70 DEGREES. PHYSICIAN BELIEVES THE DEATH WAS RELATED TO ANESTHESIA USED TO SEDATE THE PT. THE STOCKERT GENERATOR AND THE PIU WERE TAKEN TO THE MGR'S OFFICE FOR THE HOSPITAL'S RISK MGMT DEPT TO LOOK AT AND THEN TO BIO MED DEPT FOR TESTING. THE CUSTOMER ALSO WOULD LIKE THE STOCKERT GENERATOR TO BE CHECKED OUT. THE F/U CONVERSATION THAT AFFILIATE HAD WITH THE LAB STAFF INDICATED THAT NONE OF THE EQUIPMENT WAS AT FAULT FOR THE PT INJURY/DEATH. INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVAL WILL BE SUBMITTED ONCE IT IS COMPLETED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PROCEDURE, THE PT'S BLOOD PRESSURE WAS LOW. THE PHYSICIAN WAS NOT ABLE TO GET THE BLOOD PRESSURE BACK UP. THEY PERFORMED CPR AND ACLS (ADVANCED CARDIAC LIFE SUPPORT) PROTOCOL. LATER ON, THE PT EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STOCKERT RF GENERATOR	DRF RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE	DRF	STOCKERT GMBH	M-5463-01

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI		Death	CARTO XP SYSTEM: MODEL #: M-4700-01\| RETURNED FOR INVESTIGATION): MODEL#:UNK, LOT#:UNK\| GENERIC-CELSIUS II BI-DIRECTIONAL THR(PRODUCT NOT\| GENERIC-NAVISTAR THERMOCOOL THR(PRODUCT NOT\| RETURNED FOR INVESTIGATION): MODEL#:UNK, LOT#:UNK