HEARTSINE SAMARITAN 300P AND PAD-PAK
Report
- Report Number
- 3004123209-2018-00557
- Event Type
- Malfunction
- Date Received
- August 27, 2018
- Date of Event
- August 1, 2018
- Report Date
- November 29, 2018
- Manufacturer
- HEARTSINE TECHNOLOGIES LTD
- Product Code
- MKJ
- PMA / PMN Number
- K014067
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SG
- Reporter Occupation
- OTHER
Narratives
THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 18TH JULY 2014. THE DEVICE WAS RETURNED WITH THE REPORTED FAULT ¿RED STATUS INDICATOR¿. DURING TESTING AT HEARTSINE, THE RED STATUS INDICATOR WAS OBSERVED TO BE FLASHING ALONG WITH THE LEFT PAD PLACEMENT LED. THE FAULT WAS TRACED BACK TO A FAILURE IN THE MEMBRANE DUE TO A BREAKDOWN IN THE CROSS-OVER INSULATION RESULTING IN LEAKAGE CURRENT BETWEEN TRACK 1 (STATUS_LED_RED) AND TRACK 2 (LEFT_PAD_LED). THIS WOULD EXPLAIN THE RED STATUS LED AND LEFT PAD LED FLASHING SIMULTANEOUSLY DURING THE POWER UP. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES WHICH HAVE BEEN RETURNED FROM THE FIELD, AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND REPLACED WITH A SAM 350P.
EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).
RED STATUS INDICATOR FLASHING. NO PATIENT INVOLVED.
RED STATUS INDICATOR FLASHING. NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 662233 | HEARTSINE SAMARITAN 300P AND PAD-PAK | AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | HEARTSINE TECHNOLOGIES LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |