HEARTSINE SAMARITAN 350P AND PAD-PAK
Report
- Report Number
- 3004123209-2018-00132
- Event Type
- Death
- Date Received
- February 15, 2018
- Date of Event
- January 23, 2018
- Report Date
- April 30, 2018
- Manufacturer
- HEARTSINE TECHNOLOGIES LTD
- Product Code
- MKJ
- PMA / PMN Number
- P160008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON TECHNOLOGIES LLC (IMPORTER BEHALF OF HEARTSINE) H3 OTHER TEXT: NOT RETURNED YET.
PATIENT INVOLVED. ENDUSER ALLEGES THAT SAM350P UNIT USED IN SCA EVENT " DID NOT SHOCK HARD ENOUGH", EVO FILE NOT PROVIDED BY ENDUSER CUSTOMER EVENT FORM SENT IN. PAD UNIT WAS REMOVED BY EMT'S AND THEY THEN USED THEIR DEFIBRILLATOR. PATIENT DID NOT SURVIVE.
INITIAL MDR RECEIVED ON FEBRUARY 15, 2018 HAS A DISCREPANCY WITH DEATH DATE AND EVENT DATE. DEATH DATE WAS BEFORE THE EVENT DATE. THIS HAS BEEN CORRECTED. DEVICE NOT RETURNED YET.
THIS IS A THIRTY DAY REPORT.
THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. NO REWORK WAS CONDUCTED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 12TH JUNE 2014. A VISUAL INSPECTION OF THE DEVICE REVEALED NO APPARENT DEFECTS. THE DEVICE HISTORY AND MEMORY LOGS WERE DOWNLOADED AND ARE ATTACHED TO THIS REPORT. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 11TH JULY 2014 AND PERFORMED TO SPECIFICATION UP TO AND INCLUDING THE LAST LOG ENTRY ON THE 28TH JANUARY 2018. DURING THIS PERIOD, THERE WERE RANDOM MANUAL POWER UPS INCLUDING 5 SEPARATE OCCASIONS WHEN THE ELECTRODE PADS WERE DETECTED AS BEING ATTACHED AND A HEART RHYTHM ASSESSED. NO SHOCK THERAPY WAS DELIVERED DURING ANY OF THESE EVENTS. THE ALLEGED DEFICIENCY OF ¿DID NOT SHOCK HARD ENOUGH¿ WAS NOT CONFIRMED. FURTHER INFORMATION WAS SOUGHT REGARDING HOW THE END USER CONCLUDED THAT THE DEVICE DID NOT SHOCK HARD ENOUGH, BUT NO REPLY WAS RECEIVED. INFORMATION TAKEN FROM THE DEVICE MEMORY, DURING THE EVENT, SHOWS THE DEVICE DID CORRECTLY CHARGE AND DELIVER A SHOCK ENERGY CONSISTENT WITH A 150J. HOWEVER, THIS DID NOT RESULT IN THE PATIENT ACHIEVING RETURN TO SPONTANEOUS CIRCULATION (ROSC). THE SAM 350P INCORPORATES AN ESCALATING SHOCK ENERGY PROTOCOL OF 150J, 150J AND 200J; HOWEVER, THE PADS WERE REMOVED FROM THE PATIENT SHORTLY AFTER THE 1ST SHOCK WAS DELIVERED. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE (B)(4).
PATIENT INVOLVED. ENDUSER ALLEGES THAT SAM350P UNIT USED IN SCA EVENT " DID NOT SHOCK HARD ENOUGH", EVO FILE NOT PROVIDED BY ENDUSER CUSTOMER EVENT FORM SENT IN. PAD UNIT WAS REMOVED BY EMT'S AND THEY THEN USED THEIR DEFIBRILLATOR. PATIENT DID NOT SURVIVE.
PATIENT INVOLVED. ENDUSER ALLEGES THAT SAM350P UNIT USED IN SCA EVENT " DID NOT SHOCK HARD ENOUGH", EVO FILE NOT PROVIDED BY ENDUSER CUSTOMER EVENT FORM SENT IN. PAD UNIT WAS REMOVED BY EMT'S AND THEY THEN USED THEIR DEFIBRILLATOR. PATIENT DID NOT SURVIVE
PATIENT INVOLVED. END USER ALLEGES THAT SAM350P UNIT USED IN SCA EVENT " DID NOT SHOCK HARD ENOUGH", EVO FILE NOT PROVIDED BY END USER CUSTOMER EVENT FORM SENT IN. PAD UNIT WAS REMOVED BY EMT'S AND THEY THEN USED THEIR DEFIBRILLATOR. PATIENT DID NOT SURVIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118547 | HEARTSINE SAMARITAN 350P AND PAD-PAK | AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | HEARTSINE TECHNOLOGIES LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death |