FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
MDR report key: 4760430
·
Received May 8, 2015
Report
- Report Number
- 3010617000-2015-00263
- Event Type
- Malfunction
- Date Received
- May 8, 2015
- Date of Event
- April 16, 2015
- Report Date
- April 17, 2015
- Manufacturer
- ZOLL CIRCULATION
- Product Code
- DRM
- PMA / PMN Number
- K112998
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE UPON POWER UP WITH TWO SEPARATE BATTERIES. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302845 | AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION | MODEL 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |