FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE RESUSCSITATION SYSTEM MODEL 100
MDR report key: 3003682
·
Received February 11, 2013
Report
- Report Number
- 3003793491-2013-00265
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 14, 2013
- Report Date
- January 16, 2013
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION 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 AUTOPULSE PLATFORM'S DISPLAY PANEL WAS BLANKING AND THAT THE DEVICE DID NOT SHOW ANY MESSAGES. HOWEVER, IT CAN STILL BE USED TO DELIVER THERAPY. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59226 | AUTOPULSE RESUSCSITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC. | MODEL 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |