FDA Adverse Event
Death
Summary report: N
AED PLUS
MDR report key: 2221339
·
Received August 17, 2011
Report
- Report Number
- 1220908-2011-02402
- Event Type
- Death
- Date Received
- August 17, 2011
- Date of Event
- July 14, 2011
- Report Date
- July 26, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K011541
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT AIRPORT PARAMEDICS RESPONDED TO A CALL FOR A (B)(6) MALE PT HAVING A CARDIAC EPISODE INSIDE AN AIRPORT PARKING LOT. UPON ARRIVAL, THE PT WAS FOUND LYING ON THE GROUND AND WAS BLUE IN COLOR. THE DEVICE WAS ATTACHED TO THE PT, RETURNED A "SHOCK ADVISED" DETERMINATION AND THEN STATED "NO SHOCK DELIVERED" AND "CHANGE BATTERIES" MESSAGES. COMPLAINANT INDICATED THAT EMS PERSONNEL ARRIVED UPON THE SCENE WITH ANOTHER DEFIBRILLATOR. THE PT WAS TRANSPORTED TO THE HOSP AND SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED PLUS | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | AED PLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death |