FDA Adverse Event
Death
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 2190469
·
Received July 28, 2011
Report
- Report Number
- 1220908-2011-02114
- Event Type
- Death
- Date Received
- July 28, 2011
- Date of Event
- June 26, 2011
- Report Date
- July 7, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K042007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT MEDICS RESPONDED TO A CALL FOR A (B)(6), FEMALE PT IS UNWITNESSED CARDIAC ARREST THE DEVICE WAS ATTACHED TO THE PT AND THE DEVICE APPROPRIATELY RETURNED A "NO SHOCK ADVISED" FOR THE PRESENTED ASYSTOLIC RHYTHM. THE DEVICE THEN RETURNED A "SHOCK ADVISED" DETERMINATION FOR WHAT APPEARED TO BE AN ASYSTOLIC RHYTHM, AND THE DEVICE DELIVERED ENERGY. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORPORATION | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death |