FDA Adverse Event Malfunction Summary report: N

X SERIES

MDR report key: 24769623 · Received April 2, 2026

Report

Report Number: 1220908-2026-01046
Event Type: Malfunction
Date Received: April 2, 2026
Date of Event: March 8, 2026
Report Date: March 11, 2026
Manufacturer: ZOLL MEDICAL CORPORATION
Product Code: MKJ
PMA / PMN Number: P160022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BEFORE UDI REQUIREMENTS. THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION. DURING THE INVESTIGATION IT WAS NOTED THAT THE REPORTED PROBLEM WAS UNABLE TO BE DUPLICATED. LOGS WERE REVIEWED AND FOUND EVIDENCE OF ECG MONITORING FAILURE IN CONJUNCTION WITH RAPID CABLE ID CHANGES IN THE SAME EVENT SUGGESTING MULTIFUNCTION CABLE (MFC) CONNECTION TO THE DEVICE WAS A FACTOR. THE CUSTOMER'S MFC WAS NOT RETURNED FOR EVALUATION. BENCH TESTING AND ECG STRESSING WERE PERFORMED ON THE X SERIES WITH A TEST MFC WITHOUT DUPLICATING THE CUSTOMER'S REPORT OR ANY MALFUNCTION TO THE DEVICE. THE MFC RECEPTACLE WAS REPLACED AND A NEW MFC CABLE WILL BE SENT TO THE CUSTOMER AS A PRECAUTION. NO EMERGING TREND BASED ON SIMILAR REPORTS.

Description of Event or Problem · 0

COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG MONITORING FAILURE" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
832451	X SERIES	DEFIBRILLATOR/PACEMAKER	MKJ	ZOLL MEDICAL CORPORATION	610-2231411-01	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown