FDA Adverse Event
Death
Summary report: N
HEARTSINE SAMARITAN 500P AND PAD PAK
MDR report key: 7057682
·
Received November 24, 2017
Report
- Report Number
- 3004123209-2017-01416
- Event Type
- Death
- Date Received
- November 24, 2017
- Date of Event
- May 23, 2017
- Report Date
- November 17, 2017
- Manufacturer
- HEARTSINE TECHNOLOGIES LTD
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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). EVENT DATE WAS CORRECT TO DEATH DATE.
Description of Event or Problem · 0
THERE WAS A PATIENT INVOLVED IN THIS EVENT. PATIENT DIED. DEVICE RETURNED FOR FURTHER INVESTIGATION OF MEMORY ISSUE.
Description of Event or Problem · 0
THERE WAS A PATIENT INVOLVED IN THIS EVENT. PATIENT DIED. DEVICE RETURNED FOR FURTHER INVESTIGATION OF MEMORY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837074 | HEARTSINE SAMARITAN 500P AND PAD PAK | AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | HEARTSINE TECHNOLOGIES LTD | SAM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Death |