FDA Adverse Event
Malfunction
Summary report: N
POWEHEART AED
MDR report key: 1052844
·
Received May 27, 2008
Report
- Report Number
- 3014398-2008-00015
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- April 25, 2008
- Report Date
- May 27, 2008
- Manufacturer
- CARDIAC SCIENCE CORPORATION
- Product Code
- MKJ
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO THE CARDIAC SCIENCE. ONCE THE PROD IS AVAILABLE, AN INVESTIGATION WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN THE FOLLOW-UP REPORTS.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT DURING AN ATTEMPTED RESCUE THE AED DID NOT FUNCTION PROPERLY. WHEN ATTEMPTING TO PERFORM THE RESCUE, THE DEVICE WOULD NOT RECOGNIZE THE 2ND PAD PLACEMENT AND CONTINUED TO ADVISE "TO PLACE 2ND PAD". THEY ATTEMPTED TO USE NEW SET OF ELECTRODES, BUT THEY RECEIVED THE SAME MESSAGE. AED WOULD NOT PROCEED FURTHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWEHEART AED | AUTOMATIC EXTERNAL DEFIBRILLATOR | MKJ | CARDIAC SCIENCE CORPORATION | 9300E-501 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |