FDA Adverse Event Death Summary report: N

ELECTRODES, ONESTEP COMPLETE

MDR report key: 7078583 · Received December 4, 2017

Report

Report Number: 1218058-2017-00130
Event Type: Death
Date Received: December 4, 2017
Date of Event: October 23, 2017
Report Date: November 13, 2017
Manufacturer: BIO-DETEK INCORPORATED
Product Code: MKJ
UDI-DI: 00847946016272
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

Additional Manufacturer Narrative · 1

THIS REPORT WAS INADVERTENTLY SUBMITTED AS A DUPLICATE. THE REPORTED EVENT WAS ORIGINALLY REPORTED UNDER MEDWATCH 1218058-2017-00129. A SUPPLEMENTAL MEDWATCH REPORT FOR 1218058-2017-00129 WAS RECENTLY SUBMITTED ON 2-12-2018. EVALUATION RESULTS WERE AS FOLLOWS: THE ELECTRODES WERE RETURNED TO ZOLL MEDICAL CORPORATION AND THE CUSTOMER'S REPORT WAS OBSERVED. THE HIGH VOLTAGE WIRE WAS OBSERVED TO BE DETACHED CONSISTENT WITH THE CUSTOMER'S REPORT. FURTHER INVESTIGATION AT THE POINT OF ENGAGEMENT SHOWED EVIDENCE THAT A FORCE PULLED IT AWAY FROM THE CONNECTION. RETAINED SAMPLE TESTING FOR THIS LOT NUMBER CONFIRMED THAT THERE WERE NO IRREGULARITIES ASSOCIATED WITH THIS CUSTOMER REPORT. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

Description of Event or Problem · 1

COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), A WIRE HAD BECOME DISLODGED FROM THE ELECTRODE PAD. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODES TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
859972	ELECTRODES, ONESTEP COMPLETE	ELECTRODE	MKJ	BIO-DETEK INCORPORATED	8900-0224-01	0317A	00847946016272

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death