FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 19508902
·
Received June 11, 2024
Report
- Report Number
- 1220908-2024-02087
- Event Type
- Malfunction
- Date Received
- June 11, 2024
- Report Date
- May 23, 2024
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946019273
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS EVALUATED BY ZOLL MEDICA CORPORATION. THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO THE MONITOR BOARD. THE MONITOR BOARD WILL BE REPLACED TO RESOLVE THE REPORT. THE DEVICE WILL BE RECERTIFIED AND RETURNED TO THE CUSTOMER ONCE THE REPAIR ESTIMATE HAS BEEN APPROVED. ANAYSIS FOR THE REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 0
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE RESTART/REBOOT ITSELF MULTIPLE TIMES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 823224 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | X SERIES | NA | 00847946019273 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |