FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 2982275
·
Received January 25, 2013
Report
- Report Number
- 3003793491-2013-00037
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- December 26, 2012
- Report Date
- December 26, 2012
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED. NO ADVERSE EVENT REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PLATFORM GAVE ABOUT 5 MINS OF COMPRESSION BEFORE DISPLAYING USER ADVISORY 45 (NOT AT HOME POSITION AFTER POWER-ON/RESTART), AND USER ADVISORY 9 (DISCREPANCY BETWEEN SOFTWARE AND HARDWARE LOAD PLATE TOO LARGE). MEDICS PERFORMED CPR, THERE WAS NO ADVERSE EFFECTS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36494 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC. | MODEL 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |