FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 2982279
·
Received January 25, 2013
Report
- Report Number
- 3003793491-2013-00225
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- December 27, 2012
- Report Date
- December 27, 2012
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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 DEVICE AUTOMATICALLY POWERS ON WHEN BATTERY IS INSERTED AND WITHIN FIVE MINS, IT SHUTS OFF FLASHES LOW BATTERY. IT SHUTS OFF WITH NO WARNING. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35490 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC. | MODEL 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |