FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 3063623
·
Received March 29, 2013
Report
- Report Number
- 3003793491-2013-00419
- Event Type
- Malfunction
- Date Received
- March 29, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 8, 2013
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- PMA / PMN Number
- K112998
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A WEEKLY CHECK, THE PLATFORM INDICATED USER ADVISORY 02 (COMPRESSION TRACKING ERROR), USER ADVISORY 21 (POSITION CHANGE DOES NOT COINCIDE WITH MOTOR DIRECTION) AND USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESET) MESSAGES. THERE WAS NO PT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130019 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC. | MODEL 100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |