FDA Adverse Event
Malfunction
Summary report: N
HEARTSINE TECHNOLOGIES SAMARITAN 300/300P PAD PUBLIC ACCESS DEFIBRILLATORS
MDR report key: 3365712
·
Received September 19, 2013
Report
- Report Number
- MW5031963
- Event Type
- Malfunction
- Date Received
- September 19, 2013
- Date of Event
- September 16, 2013
- Report Date
- September 18, 2013
- Manufacturer
- HEARTSINE TECHNOLOGIES INC
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HEARTSINE TECHNOLOGIES SAMARITAN 300/300P PAD PUBLIC ACCESS DEFIBRILLATORS: RECALL POWER, BATTERY ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472391 | HEARTSINE TECHNOLOGIES SAMARITAN 300/300P PAD PUBLIC ACCESS DEFIBRILLATORS | HEARTSINE TECHNOLOGIES SAMARITAN 300/300P PAD PUBLIC ACCESS DEFIBRILLATORS | MKJ | HEARTSINE TECHNOLOGIES INC | SAM 300P | B0053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |