FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 23871856
·
Received December 22, 2025
Report
- Report Number
- 1220908-2025-04703
- Event Type
- Malfunction
- Date Received
- December 22, 2025
- Report Date
- December 4, 2025
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946014858
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED TO BE CAUSED BY DEFIB/PACE FLEX BRIDGE CABLE PINS DAMAGE. THE DEFIB/PACE FLEX BRIDGE CABLE WAS REPLACED TO REMEDY THE ISSUE. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Additional Manufacturer Narrative · 0
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 0
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST FOR DEFIB FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1621892 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | 610-0211011-01 | NA | 00847946014858 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |