3004123209-2018-00712
Report
- Report Number
- 3004123209-2018-00712
- Event Type
- Malfunction
- Date Received
- November 29, 2018
- Date of Event
- November 1, 2018
- Report Date
- January 21, 2019
- PMA / PMN Number
- K014067
- Removal / Correction Number
- Z-0124-2013
- 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 23RD AUGUST 2011. THE DEVICE WAS RETURNED WITH THE REPORTED FAULT ¿AED SHOCK BUTTON FAULTY¿. INFORMATION FROM THE HISTORY LOG SHOWS THAT THE DEVICE PERFORMED ALL WEEKLY AUTO SELF-TESTS FROM INSTALLATION ON THE (B)(6) 2011 UP TO THE LAST LOG ENTRY. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0°C AND 50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS IS EQUIVALENT TO APPROXIMATELY 33 MONTHS OF NORMAL USE WITHOUT FAULT. THE SHOCK BUTTON WAS VERIFIED USING THE SAVEREVO DIAGNOSTIC TOOL DURING TESTING. THEREFORE, IT IS POSSIBLE THAT INCORRECT USE OF SAVEREVO DIAGNOSTIC TEST TOOL MAY HAVE CAUSED THE REPORTED FAULT OBSERVED. THE RETURNED SAM 300P IS NOW OUTSIDE OF ITS WARRANTY PERIOD AND WILL BE SCRAPPED.
EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).
AED SHOCK BUTTON FAULTY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
AED SHOCK BUTTON FAULTY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |