FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 2935807
·
Received January 2, 2013
Report
- Report Number
- 3003793491-2012-00687
- Event Type
- Malfunction
- Date Received
- January 2, 2013
- Date of Event
- October 5, 2012
- Report Date
- October 5, 2012
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE A PATIENT WAS ON THE BOARD, THE USER HEARD A CRACKLING NOISE AND THE DEVICE STOPPED WORKING THEN AND THERE. THE BOARD WAS FOUND TO HAVE A SPLIT ON EACH SIDE OF THE BOARD AND WILL NOT WORK AT ALL. THIS IS ALL THE INFORMATION USER HAS AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1608 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC. | MODEL 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |