FDA Adverse Event Death Summary report: N

X SERIES

MDR report key: 20067147 · Received August 26, 2024

Report

Report Number: 1220908-2024-03047
Event Type: Death
Date Received: August 26, 2024
Date of Event: August 3, 2024
Report Date: August 5, 2024
Manufacturer: ZOLL MEDICAL CORPORATION
Product Code: MKJ
UDI-DI: 00847946029616
PMA / PMN Number: P160022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING ANY MALFUNCTION TO THE DEVICE. THE DEVICE WAS RECERTIFIED ND RETURNED TO THE CUSTOMER. REVIEW OF THE LOG DID SEE EVIDENCE OF THE REPORTED PROBLEM BUT DOES NOT INDICATE A DEVICE MALFUNCTION. THE LOG SUGGEST THE DEVOCE WAS IN A LEAD FAULT CONDITION WHEN PACING WAS INITIATED SUGGESTING POOR COUPLING WAS A FACTOR ON THE ECG ELECTRODES AND NOT THE PAD ELECTRODES APPLIED TO THE PATIENT. THERE ARE MULTIPLE FACTORS OUTSIDE OF A DEVICE MALFUNCTION THAT COULD CONTRIBUTE TO THIS CONDITION. SOME INCLUDE, BUT ARE NOT LIMITED TO MOTION ARTIFACTS, POOR CONTACT BETWEEN THE PADS AND THE PATIENT'S SKIN, POOR CONTACT BETWEEN THE MULTIFUNCTION CABLE AND THE ADAPTER, PATIENT SKIN CONDITION, OR AN ISSUE WITH THE ACCESSORIES. THIS REPORT HAS BEEN ATTRIBUTED TO POOR COUPLING OF THE ELECTRODE PADS TO THE PATIENT'S SKIN. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

Description of Event or Problem · 0

COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO PACE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1481998	X SERIES	DEFIBRILLATOR/PACEMAKER	MKJ	ZOLL MEDICAL CORPORATION	630-2231112-01	NA	00847946029616

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Death