FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 2982320
·
Received January 25, 2013
Report
- Report Number
- 3003793491-2013-00235
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 26, 2012
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION 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. NO ADVERSE EVENT REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PLATFORM INDICATED USER ADVISORY 139 (UNABLE TO HOLD COMPRESSION POSITION) AND STOPPED WORKING DURING COMPRESSION. THE BATTERY WAS RE-INSERTED, PLATFORM RE-STARTED COMPRESSION. HOWEVER, THE EVENT WAS DUPLICATED; USER ADVISORY 139 COULD NOT BE CLEARED. IT IS NOT KNOWN WHETHER THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35919 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC. | 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |