FDA Adverse Event Death Summary report: N

X SERIES

MDR report key: 7277271 · Received February 16, 2018

Report

Report Number: 1220908-2018-00335
Event Type: Death
Date Received: February 16, 2018
Date of Event: January 27, 2018
Report Date: January 29, 2018
Manufacturer: ZOLL MEDICAL CORPORATION
Product Code: DRT
UDI-DI: 00847946005962
PMA / PMN Number: K112432
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WY, 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

ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE CLINICAL DATA FILE FOR THIS EVENT INDICATES THAT THE DEVICE HAD HANDS FREE ELECTRODE PADS ATTACHED AND THE PADS WERE PROPERLY IDENTIFIED AND RECOGNIZED BY THE DEVICE. THE FILE SHOWED THAT THE ECG SIGNAL DID NOT DISPLAY ON THE SCREEN BECAUSE THE END USER HAD THE LEAD VIEW SELECTED RATHER THAN THE PADS VIEW. ECG LEADS WERE ALSO ATTACHED AND THE SIGNAL IS EVENTUALLY DISPLAYED VIA LEADS I AND II. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

Description of Event or Problem · 1

COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. THE CLINICIANS OBTAINED ANOTHER SET OF ELECTRODE PADS AND WERE UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
120859	X SERIES	DEFIBRILLATOR/PACEMAKER	DRT	ZOLL MEDICAL CORPORATION	X SERIES	NA	00847946005962

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Death