X SERIES
Report
- Report Number
- 1220908-2023-01456
- Event Type
- Malfunction
- Date Received
- April 25, 2023
- Date of Event
- January 23, 2023
- Report Date
- April 4, 2023
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946005818
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE DEVICE LOG WAS PROVIDED. A REVIEW OF THE PROVIDED DEVICE LOG SHOWED THE NO ECG SIGNAL WAS RELATED TO LEADS VIEW. TWO MINUTES AFTER A SUCCESSFUL 12 LEAD ACQUISITION, THE SIGNAL IS LOST AND COMES BACK FOR A SECOND AT MOST A FEW TIMES. IT APPEARS AFTER A FEW MINUTES TROUBLESHOOTING WAS PERFORMED AND THEN THE DEFIB PADS ARE APPLIED, LEAD CHANGED TO PADS, AND SIGNAL ACQUIRED FOR THE REST OF THE CASE. IT APPEARS THAT THE ECG SIGNAL VIA LEADS HAS POOR PAD CONTACT WHICH CAUSED THE DEVICE NOT TO DISPLAY THE SIGNAL VIA ECG LEADS. REVIEW OF THE LOGS CONFIRMED THE DEVICE WAS CAPABLE OF ACQUIRING THE SIGNAL WHEN ALL CRITERIA WERE MET, AS THE SIGNAL HAD BEEN OBTAINED IN THE CASE. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 45-YEAR-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. 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 |
|---|---|---|---|---|---|---|---|
| 1186217 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | X SERIES | NA | 00847946005818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male |