FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 3150040
·
Received May 20, 2013
Report
- Report Number
- 3003793491-2013-00567
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 25, 2013
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- PMA / PMN Number
- K112998
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL CIRCULATION 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, WHILE UNDER EVALUATION, AN AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY 16 MESSAGE. THIS FAULT COULD NOT BE CLEARED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. MFR REQUESTED ADDITIONAL INFORMATION ON (B)(4) 2013, HOWEVER NO FURTHER DETAILS HAVE BEEN OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221556 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC. | MODEL 100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |