3004123209-2018-00506
Report
- Report Number
- 3004123209-2018-00506
- Event Type
- Death
- Date Received
- August 6, 2018
- Date of Event
- July 9, 2018
- Report Date
- August 31, 2018
- PMA / PMN Number
- P160008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).
THIS WAS A PATIENT INVOLVED EVENT WHICH OCCURED IN (B)(6). PATIENT HAD A HISTORY OF BLOOD CLOTS AND PREVIOUS MI. NO SHOCK WAS DELIVERED. THE ENDUSER ALLEGES THAT SAM350P UNIT DID NOT READ HEART RHYTHM DURING THIS EVENT. A SECOND SAM350P UNIT WAS USED AND SHOCK WAS ADVISED AND DELIVERED HOWEVER THE PATIENT DID NOT SURVIVE. THE ENDUSER ALLEGES THAT THE WIRE TO THE ELECTRODE OF THE FIRST DEVICE MAY HAVE POSSIBLY BROKEN DURING EVENT.
THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 21ST MARCH 2014. THE PAD-PAK DHR FOR LOT NO. A1738 WAS REVIEWED AND SHOWED THAT THIS WAS 1 OF 100 PAD-PAKS MANUFACTURED IN THIS LOT ON THE 10TH APRIL 2014. EACH PAD-PAK WAS SUBJECT TO A BATTERY AND ELECTRODE TEST WITH NO RECORDED FAILS. NINETY-EIGHT (98) PAD-PAKS WERE SENT FROM THIS LOT TO HEARTSINE INC. ON THE 10TH APRIL 2014. THE DEVICE WAS POWERED ON AND THE USER WAS ISSUED WITH THE ADVISORY SPEECH PROMPTS, 50 SECONDS INTO THE EVENT THE ELECTRODE PADS WERE DETECTED AS BEING ATTACHED TO THE PATIENT. THE PATIENCE IMPEDANCE VARIED THROUGHOUT THE 2 MINUTE AND 46 SECONDS EVENT RESULTING IN PADS DETECTED AS BEING ON AND THEN SUDDENLY OFF. THE PATIENT¿S HEART RHYTHM PRESENTED AS VENTRICULAR FIBRILLATION. THE ALGORITHM WAS ABLE TO ASSESS THE RHYTHM AND A SHOCK WAS ADVISED BUT NO SHOCK WAS DELIVERED DURING THE EVENT. DURING THE INVESTIGATION, THE DEVICE WAS FOUND TO BE CORRECTLY MEASURING IMPEDANCE THROUGHOUT THE RANGE EVEN UNDER THE STRESS OF ELEVATED TEMPERATURE. THE RETURNED PAD-PAK FROM LOT A1738 HAD SUSTAINED DAMAGE. THE STERNUM ELECTRODE PAD HAD BEEN TORN FROM THE CONNECTING LEAD. THE INVESTIGATION WAS UNABLE TO DETERMINE WHEN THIS HAPPENED BUT IF THE DAMAGED HAD OCCURRED DURING THE EVENT IT WOULD ACCOUNT FOR THE ¿CHECK PADS¿ PROMPT AND THE FLUCTUATION IN PATIENT IMPEDANCE. INFORMATION TAKEN DURING COMPLAINT INTAKE HAD SUGGESTED THAT THIS MAY HAVE BEEN THE CASE. A 2ND SAM 350P AND PAD-PAK WAS REPORTED [4] AS BEING USED DURING THIS EVENT WITH A SHOCK REPORTEDLY DELIVERED. GIVEN NO FAULT FOUND WITH THIS DEVICE, 14D00810257, AND THE DAMAGE SEEN ON THE RETURNED PAD-PAK, IT IS PLAUSIBLE THAT THE REPORTED FAULT WAS DUE TO THE DAMAGED SUSTAINED TO PAD-PAK A1738. ALTERNATIVELY, THE FAULT MAY HAVE BEEN DUE TO PAD POSITIONING, THE PRESENCE OF HAIR OR CONDUCTIVE MATERIAL FOR EXAMPLE. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE H001-003-080.
THIS WAS A PATIENT INVOLVED EVENT WHICH OCCURED IN (B)(6). PATIENT HAD A HISTORY OF BLOOD CLOTS AND PREVIOUS MI. NO SHOCK WAS DELIVERED. THE ENDUSER ALLEGES THAT SAM350P UNIT DID NOT READ HEART RHYTHM DURING THIS EVENT. A SECOND SAM350P UNIT WAS USED AND SHOCK WAS ADVISED AND DELIVERED HOWEVER THE PATIENT DID NOT SURVIVE. THE END USER ALLEGES THAT THE WIRE TO THE ELECTRODE OF THE FIRST DEVICE MAY HAVE POSSIBLY BROKEN DURING EVENT.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |