FDA Adverse Event
Death
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 3054838
·
Received April 8, 2013
Report
- Report Number
- 3003793491-2013-00427
- Event Type
- Death
- Date Received
- April 8, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- PMA / PMN Number
- K112998
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS RECEIVED THE DEVICE ASSOCIATED WITH THIS REPORT; HOWEVER, THE DEVICE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. NIMH BATTERY S/N (B)(4), MFR REPORT# 3003793491-2013-00428. NIMH BATTERY S/N (B)(4), MFR REPORT# 3003793491-2013-00429.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PT USE NIMH BATTERY WITH S/N (B)(4) LASTED 15 MINS. THE SECOND BATTERY S/N (B)(4) GAVE 3 COMPRESSIONS. CUSTOMER INDICATED THAT THE BATTERIES ARE ROTATED AND TESTED PROPERLY. CREW REVERTED TO MANUAL CPR. PT WAS A FEMALE IN (B)(6), SHE DID NOT SURVIVE. CAUSE OF DEATH / AUTOPSY REPORT HAS NOT BEEN COMPLETED YET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142265 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC. | MODEL 100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Death| O | MANUAL COMPRESSION |