AED PRO
Report
- Report Number
- 1220908-2023-03499
- Event Type
- Malfunction
- Date Received
- September 12, 2023
- Date of Event
- July 31, 2023
- Report Date
- August 22, 2023
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS NOT CONFIRMED OR REPLICATED. NO ACCESSORIES WERE RETUNRED FOR EVALUATION. THE REVIEW OF DEVICE LOG INDICATED SIGNS OF NO SIGNAL AND LOSS OF SIGNAL. THERE ARE MULTIPLE FACTORS THAT CAN AFFECT THE ECG SIGNAL INCLUDING ELECTRODE APPLICATION, PATEINT PREPARATION AND CONDITION. THERE WERE OCCURENCES WHERE THE SIGNAL IS A FLAT LINE, AND TROUBLESHOOTING OCCURRED. THE ORIGINAL ELECTRODE SIGNAL APPEARED INTERMITTENTLY, BEFORE WHAT LOOKS TO BE ELECTRODE REPLACEMENT BY THE USER. THIS SUGGESTS THAT THE ORGINIAL ELECTRODES WORKED WHEN ALL CRITERIA WAS MET. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1145226 | AED PRO | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | AED PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |