FDA Adverse Event
Death
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 3098799
·
Received April 29, 2013
Report
- Report Number
- 3003793491-2013-00493
- Event Type
- Death
- Date Received
- April 29, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 3, 2013
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- PMA / PMN Number
- K112998
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER STATED THAT "THEY WILL KEEP AN EYE ON THE PLATFORM AND WILL ISOLATE THE BATTERY IF THIS HAPPENS AGAIN". THE PLATFORM WILL NOT BE RETURNED TO ZOLL CIRCULATION FOR INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE AUTOPULSE SCREEN WENT BLANK AND THE DEVICE POWERED OFF WHILE IN USE WITH A PT. THE DEVICE WAS POWERED BACK ON WITH THE SAME BATTERY, DEVICE FUNCTIONED AND THERAPY WAS ABLE TO BE CONTINUED. THIS OCCURRED THREE TIMES ON THE SAME PT. PT EXPIRED, HOWEVER, CUSTOMER INDICATED THAT PT OUTCOME WAS NOT ATTRIBUTED TO ANY FAULT ASSOCIATED WITH THE AUTOPULSE PLATFORM. ADD'L DETAILS WERE REQUESTED BY THE MFR CONCERNING CAUSE AND DATE OF DEATH, HOWEVER, CUSTOMER WAS UNABLE TO PROVIDE THIS INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184182 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC. | 100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |