AED PRO
Report
- Report Number
- 1220908-2024-02487
- Event Type
- Death
- Date Received
- July 12, 2024
- Date of Event
- February 26, 2024
- Report Date
- June 21, 2024
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946016142
- PMA / PMN Number
- P160022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.
ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. A REVIEW OF THE CLINICAL LOG FOR THE REPORTED EVENT DATE OBSERVED THE FIRST ANALYSIS EVENT HAD TWO OF THE THREE SEGMENTS NOT MATCH ANY OF THE ALGORITHMIC DEFINITIONS FOR SHOCKABLE OR NON-SHOCKABLE RHYTHMS. BOTH SEGMENTS HAD NOISE THAT COULD HAVE BEEN CAUSED BY MOTION WHICH MAY HAVE AFFECTED THE ANALYSIS RESULTS. SINCE TWO OF THE THREE SEGMENTS WERE DETERMINED TO BE NOT SHOCKABLE, THE OVERALL RESULT WAS NO SHOCK ADVISED. THE AED WORKED AS DESIGNED AND WITHIN THE LIMITATIONS OF THE TECHNOLOGY. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 64 -YEAR-OLD MALE PATIENT, THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2444263 | AED PRO | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | 90010400499991010 | NA | 00847946016142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Death |