FDA Adverse Event
Malfunction
Summary report: N
HEARTSINE SAMARITAN 300P AND PAD PAK
MDR report key: 6823514
·
Received August 28, 2017
Report
- Report Number
- 3004123209-2017-00891
- Event Type
- Malfunction
- Date Received
- August 28, 2017
- Date of Event
- August 10, 2017
- Report Date
- October 3, 2017
- 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
- GM
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). ROUTINE TESTING CONFIRMED THAT THE PAD-PAK WAS FIRST WAS INSTALLED BY THE CUSTOMER ON (B)(6) 2011. THE INVESTIGATION WAS UNABLE TO REPLICATE, OR FIND ANY EVIDENCE, OF THE REPORTED FAUT.
Description of Event or Problem · 0
NO PATIENT INVOLVED. DEVICE OBSERVED SWITCHING ON AUTOMATICALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 605792 | HEARTSINE SAMARITAN 300P AND PAD PAK | AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | HEARTSINE TECHNOLOGIES LTD | SAM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |