FDA Adverse Event
Malfunction
Summary report: N
R SERIES
MDR report key: 24321482
·
Received February 12, 2026
Report
- Report Number
- 1220908-2026-00375
- Event Type
- Malfunction
- Date Received
- February 12, 2026
- Report Date
- January 23, 2026
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946017163
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION. DURING THE INVESTIGATION IT WAS NOTED THAT THE REPORTED FAULT RELATING TO THE CANT SWITCH MODES WAS VERIFIED TO BE CAUSED BY A DEFECTIVE INTEGRATED CIRCUIT ON THE DIGITAL BOARD. THE DIGITAL BOARD WAS REPLACED TO RESOLVE THE PROBLEM. THE BOARD WAS SCRAPPED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO EMERGING TREND BASED ON SIMILAR REPORTS.
Description of Event or Problem · 0
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO SWITCH MODES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387176 | R SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | 30001000001110012 | NA | 00847946017163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |