FDA Adverse Event Death Summary report: N

X SERIES

MDR report key: 19980382 · Received August 14, 2024

Report

Report Number: 1220908-2024-03024
Event Type: Death
Date Received: August 14, 2024
Date of Event: July 25, 2024
Report Date: July 25, 2024
Manufacturer: ZOLL MEDICAL CORPORATION
Product Code: MKJ
PMA / PMN Number: P160022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTION A4. THE MULTI-FUNCTION CABLE (MFC) WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS VERIFIED AND ATTRIBUTED TO A KINKED MFC. THE CABLE IS TO BE SCRAPPED. THE X SERIES OPERATOR'S GUIDE (PN: 9650-002355-01) DETAILS THE DAILY/SHIFT CHECK PROCEDURE WHICH INCLUDES INSPECTION OF THE DEVICE AND ALL ACCESSORIES PRIOR TO USE. IT STATES, "INSPECT ALL CABLES, CORDS, AND CONNECTORS FOR SIGNS OF DAMAGE OR EXCESSIVE WEAR (CUTS IN INSULATION, FRAYING, BROKEN WIRES, DIRTY OR BENT CONNECTOR PINS). REPLACE IF DAMAGED." ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

Additional Manufacturer Narrative · 0

ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

Description of Event or Problem · 0

COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT 47-YEAR-OLD FEMALE A PATIENT, THE DEVICE FAILED TO CARDIOVERT THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
264199	X SERIES	DEFIBRILLATOR/PACEMAKER	MKJ	ZOLL MEDICAL CORPORATION	620-2231011-01	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR	Female	Death