FDA Adverse Event Death Summary report: N

LIFEVEST WCD 4000 SYSTEM

MDR report key: 4847773 · Received June 12, 2015

Report

Report Number: 3008642652-2015-03611
Event Type: Death
Date Received: June 12, 2015
Date of Event: May 4, 2015
Report Date: June 5, 2015
Manufacturer: ZOLL MANUFACTURING CORPORATION
Product Code: MVK
PMA / PMN Number: P010030
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION OF MONITOR (B)(4) AND ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT A PATIENT. MONITOR (B)(4): 03/2012 - REUSE. ELECTRODE BELT (B)(4): 08/2014 - REUSE.

Description of Event or Problem · 1

A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2014. THE PATIENT EXPERIENCED A TREATMENT EVENT. THE PATIENT WAS IN THE HOSPITAL AND WAS NOT CONSCIOUS AT THE TIME OF THE EVENT. DOWNLOADED ECG DATA WAS ANALYZED BY A ZOLL ECG TECHNICIAN. THE ZOLL ECG TECHNICIAN CONCLUDED THAT THERE IS EVIDENCE OF CPR ARTIFACT WITHIN THE ECG STRIPS. AT 17:09:01, THE PATIENT RECEIVED AN INAPPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF THE TREATMENT WAS CPR ARTIFACT AND THE POST SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 15BPM WITH TACTILE ARTIFACT. CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. AT 17:09:28 A NON-TREATABLE RHYTHM WAS DETECTED. THE ELECTRODE BELT WAS DISCONNECTED AT 18:16:17. A REVIEW OF THE DOWNLOADED DATA CONFIRMS THAT THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PATIENT PASSED AWAY ON (B)(6) 2015.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
384094	LIFEVEST WCD 4000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL MANUFACTURING CORPORATION	WCD 4000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Death