FDA Adverse Event
Malfunction
Summary report: N
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
MDR report key: 7701794
·
Received July 19, 2018
Report
- Report Number
- 3004123209-2018-00456
- Event Type
- Malfunction
- Date Received
- July 19, 2018
- Date of Event
- June 29, 2018
- Report Date
- July 19, 2018
- Manufacturer
- HEARTSINE TECHNOLOGIES LTD
- Product Code
- MKJ
- PMA / PMN Number
- K014067
- Removal / Correction Number
- Z-0124-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). H3 OTHER TEXT : DEVICE NOT RETURNED YET.
Description of Event or Problem · 0
DEVICE SWITCHING ON AUTOMATICALLY. NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 546230 | HEARTSINE SAMARITAN 300P AND PAD-PAK K014067 | AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | HEARTSINE TECHNOLOGIES LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |