FDA Adverse Event
Death
Summary report: N
AED PRO
MDR report key: 1972295
·
Received January 20, 2011
Report
- Report Number
- 1220908-2011-00192
- Event Type
- Death
- Date Received
- January 20, 2011
- Date of Event
- December 13, 2010
- Report Date
- January 14, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PT, THE AED PRO DEVICE ISSUED A "SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THAT WAS BELIEVED TO BE NON-SHOCKABLE. THE COMPLAINANT ALLEGED THAT WHEN THE MEDICS ARRIVED ON THE SCENE, THE PT WAS RIGID, INDICATING RIGOR MORTIS. THEY IMMEDIATELY STOPPED THE RESUSCITATION PROCESS, BELIEVING THE PT WAS ALREADY DECEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED PRO | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | AED PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |